A Pragmatic Trial of E-Cigarettes, Incentives, and Drugs for Smoking Cessation.

BACKGROUND: Whether financial incentives, pharmacologic therapies, and electronic cigarettes (e-cigarettes) promote smoking cessation among unselected smokers is unknown. METHODS: We randomly assigned smokers employed by 54 companies to one of four smoking-cessation interventions or to usual care. Usual care consisted of access to information regarding the benefits of smoking cessation and to a motivational text-messaging service. The four interventions consisted of usual care plus one of the following: free cessation aids (nicotine-replacement therapy or pharmacotherapy, with e-cigarettes if standard therapies failed); free e-cigarettes, without a requirement that standard therapies had been tried; free cessation aids plus $600 in rewards for sustained abstinence; or free cessation aids plus $600 in redeemable funds, deposited in a separate account for each participant, with money removed from the account if cessation milestones were not met. The primary outcome was sustained smoking abstinence for 6 months after the target quit date. RESULTS: Among 6131 smokers who were invited to enroll, 125 opted out and 6006 underwent randomization. Sustained abstinence rates through 6 months were 0.1% in the usual-care group, 0.5% in the free cessation aids group, 1.0% in the free e-cigarettes group, 2.0% in the rewards group, and 2.9% in the redeemable deposit group. With respect to sustained abstinence rates, redeemable deposits and rewards were superior to free cessation aids (P<0.001 and P=0.006, respectively, with significance levels adjusted for multiple comparisons). Redeemable deposits were superior to free e-cigarettes (P=0.008). Free e-cigarettes were not superior to usual care (P=0.20) or to free cessation aids (P=0.43). Among the 1191 employees (19.8%) who actively participated in the trial (the "engaged" cohort), sustained abstinence rates were four to six times as high as those among participants who did not actively engage in the trial, with similar relative effectiveness. CONCLUSIONS: In this pragmatic trial of smoking cessation, financial incentives added to free cessation aids resulted in a higher rate of sustained smoking abstinence than free cessation aids alone. Among smokers who received usual care (information and motivational text messages), the addition of free cessation aids or e-cigarettes did not provide a benefit. (Funded by the Vitality Institute; ClinicalTrials.gov number, NCT02328794 .).

Randomized trial of four financial-incentive programs for smoking cessation.

BACKGROUND: Financial incentives promote many health behaviors, but effective ways to deliver health incentives remain uncertain. METHODS: We randomly assigned CVS Caremark employees and their relatives and friends to one of four incentive programs or to usual care for smoking cessation. Two of the incentive programs targeted individuals, and two targeted groups of six participants. One of the individual-oriented programs and one of the group-oriented programs entailed rewards of approximately $800 for smoking cessation; the others entailed refundable deposits of $150 plus $650 in reward payments for successful participants. Usual care included informational resources and free smoking-cessation aids. RESULTS: Overall, 2538 participants were enrolled. Of those assigned to reward-based programs, 90.0% accepted the assignment, as compared with 13.7% of those assigned to deposit-based programs (P<0.001). In intention-to-treat analyses, rates of sustained abstinence from smoking through 6 months were higher with each of the four incentive programs (range, 9.4 to 16.0%) than with usual care (6.0%) (P<0.05 for all comparisons); the superiority of reward-based programs was sustained through 12 months. Group-oriented and individual-oriented programs were associated with similar 6-month abstinence rates (13.7% and 12.1%, respectively; P=0.29). Reward-based programs were associated with higher abstinence rates than deposit-based programs (15.7% vs. 10.2%, P<0.001). However, in instrumental-variable analyses that accounted for differential acceptance, the rate of abstinence at 6 months was 13.2 percentage points (95% confidence interval, 3.1 to 22.8) higher in the deposit-based programs than in the reward-based programs among the estimated 13.7% of the participants who would accept participation in either type of program. CONCLUSIONS: Reward-based programs were much more commonly accepted than deposit-based programs, leading to higher rates of sustained abstinence from smoking. Group-oriented incentive programs were no more effective than individual-oriented programs. (Funded by the National Institutes of Health and CVS Caremark; ClinicalTrials.gov number, NCT01526265.).

Heterogeneity in the Effects of Reward- and Deposit-based Financial Incentives on Smoking Cessation.

RATIONALE: Targeting different smoking cessation programs to smokers most likely to quit when using them could reduce the burden of lung disease. OBJECTIVES: To identify smokers most likely to quit using pure reward-based financial incentives or incentive programs requiring refundable deposits to become eligible for rewards. METHODS: We conducted prespecified secondary analyses of a randomized trial in which 2,538 smokers were assigned to an $800 reward contingent on sustained abstinence from smoking, a refundable $150 deposit plus a $650 reward, or usual care. MEASUREMENTS AND MAIN RESULTS: Using logistic regression, we identified characteristics of smokers that were most strongly associated with accepting their assigned intervention and ceasing smoking for 6 months. We assessed modification of the acceptance, efficacy, and effectiveness of reward and deposit programs by 11 prospectively selected demographic, smoking-related, and psychological factors. Predictors of sustained smoking abstinence differed among participants assigned to reward- versus deposit-based incentives. However, greater readiness to quit and less steep discounting of future rewards were consistently among the most important predictors. Deposit-based programs were uniquely effective relative to usual care among men, higher-income participants, and participants who more commonly failed to pay their bills (all interaction P values < 0.10). Relative to rewards, deposits were more effective among black persons (P = 0.022) and those who more commonly failed to pay their bills (P = 0.082). Relative to rewards, deposits were more commonly accepted by higher-income participants, men, white persons, and those who less commonly failed to pay their bills (all P < 0.05). CONCLUSIONS: Heterogeneity among smokers in their acceptance and response to different forms of incentives suggests potential benefits of targeting behavior-change interventions based on patient characteristics. Clinical trial registered with www.clinicaltrials.gov (NCT 01526265).

Time to selected quit date and subsequent rates of sustained smoking abstinence.

In efforts to combat tobacco dependence, most smoking cessation programs offer individuals who smoke the choice of a target quit date. However, it is uncertain whether the time to the selected quit date is associated with participants' chances of achieving sustained abstinence. In a pre-specified secondary analysis of a randomized clinical trial of four financial-incentive programs or usual care to encourage smoking cessation (Halpern et al. in N Engl J Med 372(22):2108-2117, doi: 10.1056/NEJMoa1414293 , 2015), study participants were instructed to select a quit date between 0 and 90 days from enrollment. Among those who selected a quit date and provided complete baseline data (n = 1848), we used multivariable logistic regression to evaluate the association of the time to the selected quit date with 6- and 12-month biochemically-confirmed abstinence rates. In the fully adjusted model, the probability of being abstinent at 6 months if the participant selected a quit date in weeks 1, 5, 10, and 13 were 39.6, 22.6, 10.9, and 4.3%, respectively.

D-amphetamine, nicotine, and haloperidol produce similar disruptions in spatial and nonspatial temporal discrimination procedures.

Two different and generally noncomplimentary disruptions of timing by pharmacological agents have been found. One is a lateral shift of the psychophysical curve for time, indicating a subjective shortening or lengthening of time, whereas the other is a flattening of the curve and decrease in temporal accuracy. This study assessed the role of a methodological variation in producing this discrepancy. The procedure used required pigeons to classify stimulus duration intervals as short or long, using response alternatives that were defined either by the location of response keys (spatial), or by their color (nonspatial). D-amphetamine was used to replicate earlier findings, whereas nicotine and haloperidol extended the research to different drug classes. Dose-dependent decreases in the accuracy of classifying temporal intervals and a flattening of the psychophysical curve were found across drug classes for both spatial and nonspatial procedural variations. Procedural variations, under these conditions, could not explain the discrepancy. However, the results from this study added to the mounting body of literature showing decrements in temporal accuracy and a flattening of the psychophysical curve because of a number of diverse pharmacological and nonpharmacological disruptors.

Remote Patient Monitoring and Incentives to Support Smoking Cessation Among Pregnant and Postpartum Medicaid Members: Three Randomized Controlled Pilot Studies.

BACKGROUND: Smoking rates among low-income individuals, including those eligible for Medicaid, have not shown the same decrease that is observed among high-income individuals. The rate of smoking among pregnant women enrolled in Medicaid is almost twice that among privately insured women, which leads to significant disparities in birth outcomes and a disproportionate cost burden placed on Medicaid. Several states have identified maternal smoking as a key target for improving birth outcomes and reducing health care expenditures; however, efficacious, cost-effective, and feasible cessation programs have been elusive. OBJECTIVE: This study aims to examine the feasibility, acceptability, and effectiveness of a smartwatch-enabled, incentive-based smoking cessation program for Medicaid-eligible pregnant smokers. METHODS: Pilot 1 included a randomized pilot study of smartwatch-enabled remote monitoring versus no remote monitoring for 12 weeks. Those in the intervention group also received the SmokeBeat program. Pilot 2 included a randomized pilot study of pay-to-wear versus pay-to-quit for 4 weeks. Those in a pay-to-wear program could earn daily incentives for wearing the smartwatch, whereas those in pay-to-quit program could earn daily incentives if they wore the smartwatch and abstained from smoking. Pilot 3, similar to pilot 2, had higher incentives and a duration of 3 weeks. RESULTS: For pilot 1 (N=27), self-reported cigarettes per week among the intervention group declined by 15.1 (SD 27) cigarettes over the study; a similar reduction was observed in the control group with a decrease of 17.2 (SD 19) cigarettes. For pilot 2 (N=8), self-reported cigarettes per week among the pay-to-wear group decreased by 43 cigarettes (SD 12.6); a similar reduction was seen in the pay-to-quit group, with an average of 31 (SD 45.6) fewer cigarettes smoked per week. For pilot 3 (N=4), one participant in the pay-to-quit group abstained from smoking for the full study duration and received full incentives. CONCLUSIONS: Decreases in smoking were observed in both the control and intervention groups during all pilots. The use of the SmokeBeat program did not significantly improve cessation. The SmokeBeat program, remote cotinine testing, and remote delivery of financial incentives were considered feasible and acceptable. Implementation challenges remain for providing evidence-based cessation incentives to low-income pregnant smokers. The feasibility and acceptability of the SmokeBeat program were moderately high. Moreover, the feasibility and acceptability of remote cotinine testing and the remotely delivered contingent financial incentives were successful. TRIAL REGISTRATION: ClinicalTrials.gov NCT03209557; https://clinicaltrials.gov/ct2/show/NCT03209557.

Effects of acute and chronic d-amphetamine on two variations of a temporal discrimination procedure.

This study assessed temporal discrimination using a procedure in which pigeons classified temporal intervals as short or long based on different responses following visually presented stimulus durations. For the Location group, response alternatives were defined by the location of response keys, whereas for the Color group response alternatives were defined by key color. Temporal parameters were derived from psychophysical curves for time, and the impact of d-amphetamine was determined during acute and chronic dosing. Results showed that classification of temporal intervals was disrupted dose dependently during the acute drug assessment, regardless of the procedural variation. During the chronic drug assessment, differences in one of the psychophysical parameters, Range, were found between groups, as well as a significant effect of Dose on Standard Deviation values in the Color group. These data suggest that procedural variation does not lead to differential effects of d-amphetamine when administered in an acute regimen; however, differences found during chronic administration suggest that procedural variations may influence the development of tolerance as evidenced by differing Range values between groups and marked disruption of Standard Deviation values at the low dose in the Color group. The influence exerted on temporal behavior and tolerance by procedural variations during acute and chronic regimens of d-amphetamine should be explored further.

ABA chronic dosing of D-amphetamine produces differential drug effects in two variants of a temporal discrimination procedure in pigeons.

The impact of two procedural variants of the matching to sample of duration procedure on the effects of chronically administered D-amphetamine on temporal discrimination was assessed. The task consisted of subjects classifying durations as short or long to produce a psychophysical curve for time. Procedural variations included response alternatives being defined by either the location of the response keys (Location), or by their color (Color). During Phase 1, two groups of pigeons experienced one of these procedures while being administered with D-amphetamine in an ABA chronic dosing regimen. Phase 2 was a reversal condition in which select birds from Phase 1 were trained on the other procedural variation that they had not experienced and were again given D-amphetamine in an ABA chronic regimen. Results showed that during Phase 1, subjects in the Color group showed a flattening of the psychophysical curves during amphetamine administration, whereas those in the Location group showed a shift of the psychophysical curve to the left and right. Phase 2 revealed that subjects who had experienced the Location variant first were less disrupted by the drug, even when experiencing the Color condition. The procedural variation, dosing regimen, and form of data analysis all provide more information regarding the cause of discrepancies in the timing literature regarding differential effects of D-amphetamine on timing behavior.

Effect of Process- and Outcome-Based Financial Incentives on Weight Loss Among Prediabetic New York Medicaid Patients: A Randomized Clinical Trial.

PURPOSE: To determine whether different financial incentives are effective in promoting weight loss among prediabetic Medicaid recipients. DESIGN: Four-group, multicenter, randomized clinical trial. SETTING AND PARTICIPANTS: Medicaid managed care enrollees residing in New York, aged 18 to 64 years, and diagnosed as prediabetic or high risk for diabetes (N = 703). INTERVENTION: In a 16-week program, participants were randomly assigned to one of 4 arms: (1) control (no incentives), (2) process incentives for attending weekly Diabetes Prevention Program sessions, (3) outcome incentives for achieving weekly weight loss goals, and (4) combined process and outcome incentives. MEASURES: Weight loss over a 16-week period; proportion who completed educational sessions; proportion who met weight loss goals. ANALYSIS AND RESULTS: No intervention arm achieved greater reduction in weight than control (outcome incentive -6.6 lb [-9.1 to -4.1 lb], process incentive -7.3 lb [-9.5 to -5.1 lb], combined incentive -5.8 lb [-8.8 to -2.8 lb], control -7.9 lb [-11.1 to -4.7 lb]; all P > .29). Session attendance in the process incentive arm (50%) was significantly higher than control (31%; P < .0001) and combined incentive arms (28%; P < .0001), but not significantly higher than the outcome incentive arm (38%). CONCLUSION: Process incentives increased session attendance, but when combined at half strength with outcome incentives did not achieve that effect. There were no significant effects of either process or outcomes incentives on weight loss.

Financial Incentives for Chronic Disease Management: Results and Limitations of 2 Randomized Clinical Trials With New York Medicaid Patients.

PURPOSE: To identify whether financial incentives promote improved disease management in Medicaid recipients diagnosed with hypertension or diabetes, respectively. DESIGN: Four-group, multicenter, randomized clinical trials. SETTING AND PARTICIPANTS: Between 2013 and 2016, New York State Medicaid managed care members diagnosed with hypertension (N = 920) or with diabetes (N = 959). INTERVENTION: Participants in each 6-month trial were randomly assigned to 1 of 4 arms: (1) process incentives-earned by attending primary care visits and/or receiving prescription medication refills, (2) outcome incentives-earned by reducing systolic blood pressure (hypertension) or hemoglobin A1c (HbA1c; diabetes) levels, (3) combined process and outcome incentives, and (4) control (no incentives). MEASURES: Systolic blood pressure (hypertension) and HbA1c (diabetes) levels, primary care visits, and medication prescription refills. Analysis and Results: At 6 months, there were no statistically significant differences between intervention arms and the control arm in the change in systolic blood pressure, P = .531. Similarly, there were no significant differences in blood glucose control (HbA1c) between the intervention arms and control after 6 months, P = .939. The majority of participants had acceptable systolic blood pressure (<140 mm Hg) or blood glucose (<8.0%) levels at baseline and throughout the study. CONCLUSION: Financial incentives-regardless of whether they were delivered based on disease-relevant outcomes, process activities, or a combination of the two-have a negligible impact on health outcomes for Medicaid recipients diagnosed with either hypertension or diabetes in 2 studies in which, among other design and operational limitations, the majority of recipients had relatively well-controlled diseases at the time of enrollment.

Attitudes on technological, social, and behavioral economic strategies to reduce cellphone use among teens while driving.

OBJECTIVE: The majority of U.S. teens admit to handheld cellphone use while driving, an increasingly common cause of crashes. Attitudes toward novel cellphone applications and settings that block use while driving are poorly understood, potentially limiting uptake. We examined teens' willingness to reduce cellphone use while driving and perceptions of potential strategies to limit this behavior. METHODS: Teen drivers (n = 153) aged 16-17 who owned smartphones and admitted to texting while driving completed an online survey. Survey instruments measured willingness to give up cellphone use and perceptions of technological and behavioral economic strategies to reduce cellphone use while driving. We used chi-square tests to test the hypothesis that willingness to give up certain types of cellphone use while driving and the perceptions of strategies to reduce cellphone use while driving would differ by self-reported frequency of texting while driving in the past 30 days (low [1-5 days] vs. high [6 or more days]). RESULTS: Most teens were willing or somewhat willing to give up reading texts (90%), sending texts (95%), and social media (99%) while driving. However, they were not willing to give up navigation (59%) and music applications (43%). Those who engaged in high-frequency texting while driving were more likely to say that they were not willing to give up navigation applications (73 vs. 44%, P <.001), music applications (54 vs. 32%, P <.001), and reading texts (15 vs. 4%, P =.029). Overall, the following strategies where rated as likely to be very effective for reducing texting while driving: gain-framed financial incentives (75%), loss-framed financial incentives (63%), group-based financial incentives (58%), insurance discounts (53%), automatic phone locking while driving (54%), e-mail notifications to parents (47%), automated responses to incoming texts (42%), peer concern (18%), and parental concern (15%). Those who engaged in high-frequency texting while driving were less likely to say that following strategies would be very effective: automated responses to incoming texts (33 vs. 53%, P =.016), peer concern (9 vs. 29%, P =.002), and parental concern (9 vs. 22%, P =.025). The strongest perceived benefit of cellphone blocking apps was decreasing distraction (86%). The predominant reason for not wanting to use this technology was not wanting parents to monitor their behavior (60%). CONCLUSIONS: Promising strategies for increasing acceptance of cellphone blocking technology among teen drivers include automated screen locking and permitting hands-free navigation and music combined with behavioral economic incentives to sustain engagement.

Within-session patterns in variable-interval schedule performance: Variation with deprivation level.

Previous research has shown that patterns in operant responding may change within the course of individual experimental sessions. The proper interpretation of such changes is controversial. At least one source of this controversy may lie in unstated experimental practices across laboratories, as published reports often have failed to detail important particulars of deprivation operations. The present study was aimed at gathering descriptive data on the contribution of deprivation operations to the observation of within-session changes. In two experiments, four food deprived pigeons were exposed to a multiple variable-interval 30-s variable-interval 30-s schedule of grain presentation, wherein each grain presentation was kept constant at 5s. In Condition I, a session-entry criterion was in place that permitted the pigeon access to the daily session only if its body weight fell within controlled limits. Within-session rates of responding were generally stable. In Condition II, the entry criterion was removed and experimental sessions were conducted 6 days per week. The effect of removing the session-entry criterion was to increase body weight for all birds and decrease food intake across conditions. With no session entry criterion, robust within-session changes were observed for three of the four pigeons. The results suggest that rich schedules of reinforcement often used in the analysis of within-session changes can produce substantial reductions in deprivation levels that require up to several days to reverse. Future experiments in this area should take precautions to insure that deprivation is tightly controlled and report such measures to eliminate potential errors in replication.

Financial incentives to promote extended smoking abstinence in opioid-maintained patients: a randomized trial.

BACKGROUND AND AIMS: Prior studies by our group demonstrated the efficacy of a brief but intensive behavioral intervention for producing initial smoking abstinence among opioid-dependent patients. In the present study, our aim was to promote longer-duration abstinence in this population. Following an initial 2-week incentive intervention for smoking abstinence, we examined whether a 10-week maintenance arm involving continuation of contingent reinforcement will produce greater smoking abstinence than a similar duration of noncontingent reinforcement. DESIGN: Randomized, 12-week, parallel-group study. SETTING: Out-patient research clinic in Burlington, Vermont, USA. PARTICIPANTS: Opioid-maintained smokers (n = 88) who provided breath carbon monoxide and urinary cotinine specimens and received contingent reinforcement for smoking abstinence during weeks 1-2 (phase 1), with 63 randomized on day 14 to an extended contingent (EC; n = 31) or extended noncontingent (EN; n = 32) experimental condition for weeks 3-12 (phase 2). INTERVENTION AND CONTROL: The EC condition consisted of voucher values that escalated across consecutive negative samples until they reached $30, after which they remained at $30 per negative sample. A positive or a missing sample resulted in no vouchers for that day and reset the value of the next negative same to $9. Two consecutive negatives returned the schedule to the pre-reset value. The EN control condition consisted of vouchers delivered for providing scheduled samples, but independent of smoking status. MEASUREMENTS: The primary outcome was percentage of biochemically abstinent samples during phase 2. Secondary measures included abstinence status at final study visit, complete abstinence, participants' longest duration of continuous abstinence, cotinine and carbon monoxide (CO) levels and self-reported cigarettes per day. FINDINGS: EC participants achieved greater smoking abstinence during phase 2 than EN participants [46.7 versus 23.5% negative samples, respectively; odds ratio (OR) = 2.98, 95% confidence interval (CI) = 1.16-7.65, χ(2) 1  (=)  5.0, P = 0.02]. When longest duration of continuous abstinence was compared between experimental groups, EC participants achieved twice the mean duration of continuous abstinence compared with EN participants (3.31 versus 1.68 weeks; t61  = 1.83, P = 0.07). An effect of experimental condition was also seen on mean cotinine levels (42.5 versus 210.6 ng/ml, respectively; F1,61 =5.9, P = 0.02). CONCLUSIONS: Among opioid-maintained smokers receiving an initial period of daily contingent incentives, a contingent reinforcement intervention appears to be more effective at extending smoking abstinence than noncontingent reinforcement over 10 weeks.

Characterizing opioid withdrawal during double-blind buprenorphine detoxification.

BACKGROUND: Prescription opioid (PO) abuse has become an urgent public health issue in the United States. Detoxification is one important treatment option, yet relatively little is known about the time course and severity of opioid withdrawal during buprenorphine detoxification. METHODS: This is a secondary analysis of data from a randomized, placebo-controlled, double-blind evaluation of 1, 2, and 4-week outpatient buprenorphine tapers among primary prescription opioid (PO) abusers. The aim is to characterize the time course and severity of buprenorphine withdrawal under rigorous, double-blind conditions, across multiple taper durations, and using multiple withdrawal-related measures (i.e., self-report and observer ratings, pupil diameter, ancillary medication utilization). Participants were PO-dependent adults undergoing buprenorphine detoxification and biochemically-verified to be continuously abstinent from opioids during their taper (N = 28). RESULTS: Participants randomly assigned to the 4-week taper regimen experienced a relatively mild and stable course of withdrawal, with few peaks in severity. In contrast, the 1- and 2-week taper groups experienced stark increases in withdrawal severity during the week following the last buprenorphine dose, followed by declines in withdrawal severity thereafter. The 4-week taper group also reported significantly fewer disruptions in sleep compared to the other experimental groups. When predictors of withdrawal were examined, baseline ratings of "Expected Withdrawal Severity" was the most robust predictor of withdrawal experienced during the taper. CONCLUSION: Data from this trial may inform clinicians about the expected time course, magnitude, and pattern of buprenorphine withdrawal and aid efforts to identify patients who may need additional clinical support during outpatient buprenorphine detoxification.

Preference-adaptive randomization in comparative effectiveness studies.

BACKGROUND: Determination of comparative effectiveness in a randomized controlled trial requires consideration of an intervention's comparative uptake (or acceptance) among randomized participants and the intervention's comparative efficacy among participants who use their assigned intervention. If acceptance differs across interventions, then simple randomization of participants can result in post-randomization losses that introduce bias and limit statistical power. METHODS: We develop a novel preference-adaptive randomization procedure in which the allocation probabilities are updated based on the inverse of the relative acceptance rates among randomized participants in each arm. In simulation studies, we determine the optimal frequency with which to update the allocation probabilities based on the number of participants randomized. We illustrate the development and application of preference-adaptive randomization using a randomized controlled trial comparing the effectiveness of different financial incentive structures on prolonged smoking cessation. RESULTS: Simulation studies indicated that preference-adaptive randomization performed best with frequent updating, accommodated differences in acceptance across arms, and performed well even if the initial values for the allocation probabilities were not equal to their true values. Updating the allocation probabilities after randomizing each participant minimized imbalances in the number of accepting participants across arms over time. In the smoking cessation trial, unexpectedly large differences in acceptance among arms required us to limit the allocation of participants to less acceptable interventions. Nonetheless, the procedure achieved equal numbers of accepting participants in the more acceptable arms, and balanced the characteristics of participants across assigned interventions. CONCLUSIONS: Preference-adaptive randomization, coupled with analysis methods based on instrumental variables, can enhance the validity and generalizability of comparative effectiveness studies. In particular, preference-adaptive randomization augments statistical power by maintaining balanced sample sizes in efficacy analyses, while retaining the ability of randomization to balance covariates across arms in effectiveness analyses. TRIAL REGISTRATION: ClinicalTrials.gov, NCT01526265; 31 January 2012.

A randomized, double-blind evaluation of buprenorphine taper duration in primary prescription opioid abusers.

IMPORTANCE: Although abuse of prescription opioids (POs) is a significant public health problem, few experimental studies have investigated the treatment needs of this growing population. OBJECTIVE: To evaluate, following brief stabilization with a combination of buprenorphine hydrochloride and naloxone hydrochloride dihydrate, the relative efficacy of 1-, 2-, and 4-week buprenorphine tapering regimens and subsequent naltrexone hydrochloride therapy in PO-dependent outpatients. DESIGN, SETTING, AND PARTICIPANTS: A double-blind, 12-week randomized clinical trial was conducted in an outpatient research clinic. Following a brief period of buprenorphine stabilization, 70 PO-dependent adults were randomized to receive 1-, 2-, or 4-week tapers followed by naltrexone therapy. INTERVENTION: During phase 1 (weeks 1-5 after randomization), participants visited the clinic daily; during phase 2 (weeks 6-12), visits were reduced to thrice weekly. Participants received behavioral therapy and urine toxicology testing throughout the trial. MAIN OUTCOMES AND MEASURES: The percentage of participants negative for illicit opioid use, retention, naltrexone ingestion, and favorable treatment response (ie, retained in treatment, opioid abstinent, and receiving naltrexone at the end of the study). RESULTS: Opioid abstinence at the end of phase 1 was greater in the 4-week compared with the 2- and 1-week taper conditions (P = .02), with 63% (n = 14), 29% (n = 7), and 29% (n = 7) of participants abstinent in the 4-, 2-, and 1-week conditions, respectively. Abstinence at the end of phase 2 was also greater in the 4-week compared with the 2- and 1-week conditions (P = .03), with 50% (n = 11), 16% (n = 4), and 20% (n = 5) of participants abstinent in the 4-, 2-, and 1-week conditions, respectively. There were more treatment responders in the 4-week condition (P = .03), with 50% (n = 11), 17% (n = 4), and 21% (n = 5) of participants in the 4-, 2-, and 1-week groups considered responders at the end of treatment, respectively. Retention and naltrexone ingestion also were superior in the 4-week vs briefer tapers (both P = .04). Experimental condition (ie, taper duration) was the strongest predictor of treatment response, followed by buprenorphine stabilization dose. CONCLUSIONS AND RELEVANCE: This study represents a rigorous experimental evaluation of outpatient buprenorphine stabilization, brief taper, and naltrexone maintenance for treatment of PO dependence. Results suggest that a meaningful subset of PO-dependent outpatients may respond positively to a 4-week taper plus naltrexone maintenance intervention.

Characterizing and improving HIV and hepatitis knowledge among primary prescription opioid abusers.

BACKGROUND: The high rates of HIV and Hepatitis C (HCV) infection among opioid abusers is a serious public health problem, and efforts to enhance knowledge regarding risks for HIV/hepatitis infection in this population are important. Abuse of prescription opioids (POs), in particular, has increased substantially in the past decade and is associated with increasing rates of injection drug use and HCV infection. METHODS: This study describes the effects of a brief HIV/HCV educational intervention delivered in the context of a larger randomized, double-blind clinical trial evaluating the relative efficacy of 1-, 2-, and 4-week outpatient buprenorphine tapers and subsequent oral naltrexone maintenance for treating PO dependence. HIV- and HCV-related knowledge and risk behaviors were characterized pre- and post-intervention in 54 primary PO abusers. RESULTS: The educational intervention was associated with significant improvements in HIV (p<.001) and HCV (p<.001) knowledge. Significant improvements (p<.001) were observed on all three domains of the HIV questionnaire (i.e., general knowledge, sexual risk behaviors, drug risk behaviors) and on 21 and 11 individual items on the HIV and HCV questionnaires, respectively. Self-reported likelihood of using a condom also increased significantly (p<.05) from pre- to post-intervention. No additional changes in self-reported risk behaviors were observed. CONCLUSION: These results suggest that a brief, easy-to-administer intervention is associated with substantial gains in HIV and HCV knowledge among PO abusers and represents the necessary first step toward the dissemination of a structured prevention HIV and HCV intervention for PO abusers.

Medicaid incentive programs to encourage healthy behavior show mixed results to date and should be studied and improved.

In September 2011 the Centers for Medicare and Medicaid Services awarded $85 million in grants to ten states to test financial incentive programs to encourage healthy behavior among Medicaid enrollees with chronic diseases. There is little published evidence about the effectiveness of such incentives within the Medicaid program. We evaluated the available research from three earlier Medicaid incentive programs and found mixed results. On the one hand, in Florida only about half of the $41.3 million in available credits was "claimed" by enrollees between 2006 and 2011. On the other, Idaho's incentive program was credited with improving the proportion of children who were up-to-date on well-child visits. Our findings suggest that Medicaid incentive programs should be designed so that enrollees can understand them and so that the incentives are attractive enough to motivate participation. Medicaid incentive programs also should be subject to rigorous evaluation to more clearly establish their effectiveness.

Contingency management for behavior change: applications to promote brief smoking cessation among opioid-maintained patients.

Cigarette smoking is highly prevalent among patients who are being treated for opioid-dependence, yet there have been limited scientific efforts to promote smoking cessation in this population. Contingency management (CM) is a behavioral treatment that provides monetary incentives contingent upon biochemical evidence of drug abstinence. This paper discusses the results of two studies that utilized CM to promote brief smoking cessation among opioid-maintained patients. Participants in a pilot study were randomly assigned for a 2-week period to a Contingent group that earned monetary vouchers for providing biochemical samples that met criteria for smoking abstinence, or a Noncontingent group that earned monetary vouchers independent of smoking status (Dunn et al., 2008). Results showed Contingent participants provided significantly more smoking-negative samples than Noncontingent participants (55% vs. 5%, respectively). A second randomized trial that utilized the same 2-week intervention and provided access to the smoking cessation pharmacotherapy bupropion replicated the results of the pilot study (55% and 17% abstinence in Contingent and Noncontingent groups, respectively; Dunn et al, 2010). Relapse to illicit drug use was also evaluated prospectively and no association between smoking abstinence and relapse to illicit drug use was observed (Dunn et al., 2009). It will be important for future studies to evaluate participant characteristics that might predict better treatment outcome, to assess the contribution that pharmacotherapies might have alone or in combination with a CM intervention on smoking cessation and to evaluate methods for maintaining the abstinence that is achieved during this brief intervention for longer periods of time.