Substance use outcomes in cocaine-dependent tobacco smokers: A mediation analysis exploring the role of sleep disturbance, craving, anxiety, and depression.

BACKGROUND: Sleep disturbance may play a role in cocaine use outcomes and, hence, may be a potential therapeutic target for cocaine use disorder (CUD). Research in this area, which has largely relied on resource-intensive polysomnography, would be facilitated by identifying a self-report sleep measure predictive of CUD outcomes and by a better understanding of the mechanisms by which sleep may impact CUD outcomes. This study tested the predictive validity of the Pittsburgh Sleep Quality Index (PSQI), a self-report assessment of past-month sleep quality. To better understand potential mechanisms, mediation models relating sleep disturbance to CUD outcomes were evaluated. METHODS: This is a secondary analysis of data from cocaine-dependent (n = 290) participants in a multi-site trial evaluating smoking-cessation treatment for stimulant-dependent patients. The PSQI was collected at baseline; the outcomes of interest were cocaine and drug abstinence at end-of-treatment (weeks 9-10). Potential mediators, measured in weeks 1-8, were: cocaine craving (Brief Substance Craving Scale); and anxiety and depression symptoms (Hospital Anxiety and Depression Scale). Mediation techniques were used to evaluate mediation effects separately and jointly. RESULTS: The majority of participants (58.3%) had baseline sleep disturbance. Sleep disturbance was not a significant predictor of end-of-treatment abstinence when regressed without consideration of mediators. Cocaine craving, anxiety, and depression were significant mediators, both separately and jointly, of an effect of baseline sleep disturbance on end-of-treatment abstinence. CONCLUSION: This exploratory analysis suggests that there may be an indirect relationship between self-reported sleep quality and substance use outcomes in cocaine-dependent patients, mediated by craving, anxiety, and depression. TRIAL REGISTRATION: ClinicalTrials.gov: NCT01077024.

Evaluating Nicotine Craving, Withdrawal, and Substance Use as Mediators of Smoking Cessation in Cocaine- and Methamphetamine-Dependent Patients.

INTRODUCTION: Smoking is highly prevalent in substance dependence, but smoking-cessation treatment (SCT) is more challenging in this population. To increase the success of smoking cessation services, it is important to understand potential therapeutic targets like nicotine craving that have meaningful but highly variable relationships with smoking outcomes. This study characterized the presence, magnitude, and specificity of nicotine craving as a mediator of the relationship between SCT and smoking abstinence in the context of stimulant-dependence treatment. METHODS: This study was a secondary analysis of a randomized, 10-week trial conducted at 12 outpatient SUD treatment programs. Adults with cocaine and/or methamphetamine dependence (N = 538) were randomized to SUD treatment as usual (TAU) or TAU+SCT. Participants reported nicotine craving, nicotine withdrawal symptoms, and substance use in the week following a uniform quit attempt of the TAU+SCT group, and self-reported smoking 7-day point prevalence abstinence (verified by carbon monoxide) at end-of-treatment. RESULTS: Bootstrapped regression models indicated that, as expected, nicotine craving following a quit attempt mediated the relationship between SCT and end-of-treatment smoking point prevalence abstinence (mediation effect = 0.09, 95% CI = 0.04% to 0.14%, P < .05, 14% of total effect). Nicotine withdrawal symptoms and substance use were not significant mediators (Ps > .05, <1% of total effect). This pattern held for separate examinations of cocaine and methamphetamine dependence. CONCLUSIONS: Nicotine craving accounts for a small but meaningful portion of the relationship between smoking-cessation treatment and smoking abstinence during SUD treatment. Nicotine craving following a quit attempt may be a useful therapeutic target for increasing the effectiveness of smoking-cessation treatment in substance dependence.

Multisite, randomized, double-blind, placebo-controlled pilot clinical trial to evaluate the efficacy of buspirone as a relapse-prevention treatment for cocaine dependence.

OBJECTIVE: To evaluate the potential efficacy of buspirone as a relapse-prevention treatment for cocaine dependence. METHOD: A randomized, double-blind, placebo-controlled, 16-week pilot trial was conducted at 6 clinical sites between August 2012 and June 2013. Adult crack cocaine users meeting DSM-IV-TR criteria for current cocaine dependence who were scheduled to be in inpatient/residential substance use disorder (SUD) treatment for 12-19 days when randomized and planning to enroll in local outpatient treatment through the end of the active treatment phase were randomized to buspirone titrated to 60 mg/d (n = 35) or placebo (n = 27). All participants received psychosocial treatment as usually provided by the SUD treatment programs in which they were enrolled. Outcome measures included maximum days of continuous cocaine abstinence (primary), proportion of cocaine use days, and days to first cocaine use during the outpatient treatment phase (study weeks 4-15) as assessed by self-report and urine drug screens. RESULTS: There were no significant treatment effects on maximum continuous days of cocaine abstinence or days to first cocaine use. In the female participants (n = 23), there was a significant treatment-by-time interaction effect (χ²1 = 15.26, P < .0001), reflecting an increase in cocaine use by those receiving buspirone, relative to placebo, early in the outpatient treatment phase. A similar effect was not detected in the male participants (n = 39; χ²1 = 0.14, P = .70). CONCLUSIONS: The results suggest that buspirone is unlikely to have a beneficial effect on preventing relapse to cocaine use and that buspirone for cocaine-dependent women may worsen their cocaine use outcomes. TRIAL REGISTRATION: ClinicalTrials.gov identifier: NCT01641159.

A randomized pilot clinical trial to evaluate the efficacy of Community Reinforcement and Family Training for Treatment Retention (CRAFT-T) for improving outcomes for patients completing opioid detoxification.

BACKGROUND: Detoxification with psychosocial counseling remains a standard opioid-use disorder treatment practice but is associated with poor outcomes. This study tested the efficacy of a newly developed psychosocial intervention, Community Reinforcement Approach and Family Training for Treatment Retention (CRAFT-T), relative to psychosocial treatment as usual (TAU), for improving treatment outcomes. METHODS: A randomized, 14-week trial with follow-up visits at 6 and 9 months post-randomization conducted at two substance use disorder (SUD) treatment programs. Opioid-dependent adults (i.e., identified patient - IP) enrolled in a residential buprenorphine-detoxification program and their identified concerned significant other (CSO) was randomized to CRAFT-T (n=28 dyads) or TAU (n=24 dyads). CRAFT-T consisted of two sessions with the IP and CSO together and 10 with the CSO alone, over 14 weeks. TAU for the CSOs was primarily educational and referral to self-help. All IPs received treatment as usually provided by the SUD program in which they were enrolled. The primary outcome was time to first IP drop from treatment lasting 30 days or more. Opioid and other drug use were key secondary outcomes. RESULTS: CRAFT-T resulted in a moderate but non-significant effect on treatment retention (p=0.058, hazard ratio=0.57). When the CSO was parental family, CRAFT-T had a large and significant effect on treatment retention (p<0.01, hazard ratio=.040). CRAFT-T had a significant positive effect on IP opioid and other drug use (p<0.0001). CONCLUSION: CRAFT-T is a promising treatment for opioid use disorder but replication is needed to confirm these results.

A randomized trial of concurrent smoking-cessation and substance use disorder treatment in stimulant-dependent smokers.

OBJECTIVE: To evaluate the impact of concurrent treatments for substance use disorder and nicotine-dependence for stimulant-dependent patients. METHOD: A randomized, 10-week trial with follow-up at 3 and 6 months after smoking quit date conducted at 12 substance use disorder treatment programs between February 2010 and July 2012. Adults meeting DSM-IV-TR criteria for cocaine and/or methamphetamine dependence and interested in quitting smoking were randomized to treatment as usual (n = 271) or treatment as usual with smoking-cessation treatment (n = 267). All participants received treatment as usual for substance use disorder treatment. Participants assigned to treatment as usual with concurrent smoking-cessation treatment received weekly individual smoking cessation counseling and extended-release bupropion (300 mg/d) during weeks 1-10. During post-quit treatment (weeks 4-10), participants assigned to treatment as usual with smoking-cessation treatment received a nicotine inhaler and contingency management for smoking abstinence. Weekly proportion of stimulant-abstinent participants during the treatment phase, as assessed by urine drug screens and self-report, was the primary outcome. Secondary measures included other substance/nicotine use outcomes and treatment attendance. RESULTS: There were no significant treatment effects on stimulant-use outcomes, as measured by the primary outcome and stimulant-free days, on drug-abstinence, or on attendance. Participants assigned to treatment as usual with smoking-cessation treatment, relative to those assigned to treatment as usual, had significantly better outcomes for drug-free days at 6-month follow-up (χ(2)(1) = 4.09, P <.05), with a decrease in drug-free days from baseline of -1.3% in treatment as usual with smoking-cessation treatment and of -7.6% in treatment as usual. Participants receiving treatment as usual with smoking-cessation treatment, relative to those receiving treatment as usual, had significantly better outcomes on smoking point-prevalence abstinence (25.5% vs 2.2%; χ(2)(1) = 44.69, P < .001; OR =18.2). CONCLUSIONS: These results suggest that providing smoking-cessation treatment to illicit stimulant-dependent patients in outpatient substance use disorder treatment will not worsen, and may enhance, abstinence from nonnicotine substance use. TRIAL REGISTRATION: ClinicalTrials.gov identifier: NCT01077024.

Achieving smoking abstinence is associated with decreased cocaine use in cocaine-dependent patients receiving smoking-cessation treatment.

BACKGROUND: Past research suggests that a significant relationship exists between cigarette smoking and illicit-stimulant abuse. The present study evaluated the association between achieving smoking abstinence in response to smoking-cessation treatment (SCT) and illicit-stimulant abstinence in cocaine- and/or methamphetamine-dependent participants. METHODS: Secondary analysis of a randomized, 10-week trial conducted at 12 substance use disorder (SUD) treatment programs. Two hundred and sixty seven adults, meeting DSM-IV-TR criteria for cocaine and/or methamphetamine-dependence and interested in quitting smoking were randomized to SUD treatment as usual plus SCT consisting of weekly individual smoking cessation counseling, extended-release (XL) bupropion (300 mg/day), nicotine inhaler, and contingency management for smoking abstinence. Illicit-stimulant-abstinence was measured by self-report and urine drug screens. Smoking abstinence was assessed via self-report and carbon monoxide levels. RESULTS: A significant effect was found for the cocaine-dependent subsample (N=147) in which participants who stopped smoking were abstinent for illicit stimulants an average of 78.2% of the post-smoking-quit weeks (weeks 4-10) relative to 63.6% in participants who continued smoking (X(2)(1)=8.55, p<.01, d=0.36). No significant effects were found for the sample as a whole (N=249) or for the methamphetamine-dependent subsample (N=102). CONCLUSIONS: The present results suggest that cocaine-dependent patients achieving smoking abstinence in response to SCT might evidence not only improved smoking outcomes but improved cocaine-use outcomes as well. Future research to replicate this finding appears warranted.

Pharmacodynamics must inform statistics: an example from a cocaine dependence pharmacotherapy trial.

Background. There is no FDA-approved medication for cocaine dependence or consensus on the statistical approach for analyzing data from cocaine dependence pharmacotherapy trials. The goal of this paper is to illustrate the importance of understanding medication's pharmacodynamics when specifying the statistical model to test its efficacy. Method. Data from a double-blind placebo controlled trial of reserpine for cocaine dependence are analyzed. Since the antihypertensive properties of reserpine are well established, blood pressure data are utilized to evaluate the ability of two statistical models, one that does not take the pharmacodynamics of reserpine into account and one that does, to detect reserpine's antihypertensive effect. Results. The statistical model specified without regard to reserpine's pharmacodynamics failed to find a significant medication effect for either systolic (P = 0.49) or diastolic (P = 0.59) blood pressure. Contrariwise, the model based on the pharmacodynamics of reserpine found a significant effect for both systolic (P = 0.002) and diastolic (P = 0.004) blood pressure. Conclusions. If the pharmacodynamics of a study medication are not considered when specifying statistical models, then erroneous conclusions may be reached. This trial is registered with NCT00033033.

An Evaluation of Substance Abuse Treatment and HIV Education on Safe Sex Practices in Cocaine Dependent Individuals.

Background. There is a strong association between crack/cocaine use and increased sexual risk behavior, but little research on the efficacy of HIV education for decreasing such behavior in crack/cocaine-addicted individuals in substance abuse treatment. Method. Datasets from two cocaine dependence trials including either one or three HIV education sessions, respectively, were analyzed for changes over time in the proportion of participants practicing safe sex. A pooled dataset from two earlier trials not offering HIV education was also analyzed. Results. We included 83 participants from the 1-session trial and 65 participants from the 3-session trial. Both sets of participants evidenced a significant increase in the proportion of participants having safe sex with casual partners. Participants in the 3-session HIV education study also evidenced a significant increase in the proportion of participants having safe sex with regular partners. In the trials without HIV education, no change in safe sex practices was found, and change in condom use was observed only among female participants. Conclusions. These findings are consistent with recommendations that HIV education/counseling should be provided to individuals in substance abuse treatment. A randomized controlled trial to confirm these results may be warranted. This trial is registered with NCT00033033, NCT00086255, NCT00015106, and NCT00015132.

A tale of two stimulants: mentholated cigarettes may play a role in cocaine, but not methamphetamine, dependence.

BACKGROUND: Research suggests that mentholated cigarettes may play a role in cocaine dependence. The purpose of the present study was to expand upon the research on mentholated cigarettes and cocaine dependence and to evaluate the role of mentholated cigarettes in methamphetamine dependence. METHODS: Secondary analysis of a multisite, randomized trial evaluating the impact of smoking-cessation treatment in stimulant-dependent outpatients (N=538). Participants' reasons for concurrent use of cigarettes and illicit stimulants were assessed via self-report. Stimulant-abstinence was measured by self-report and urine drug screens. Smoking cessation was assessed via self-report and carbon monoxide levels. RESULTS: Of the 301 cocaine-dependent participants, 201 (67%) were menthol and 100 (33%) were non-menthol cigarette smokers. Cocaine-dependent participants who smoked menthol, compared to non-menthol, cigarettes were significantly more likely to report that cigarettes prolong their cocaine high (X(2)(1)=16.3, p<.0001, OR=3.58 [95% CI: 1.88-6.79]) and were less likely to be stimulant abstinent during active treatment (W=3.6, p<0.001, d=.39 [95% CI: 0.16-0.62]), at 3-month follow-up (X(2)(1)=14.4, p<0.001, OR=.32 [95% CI: 0.17-0.58]), and at 6-month follow-up (X(2)(1)=4.6, p=0.03, OR=.53 [95% CI: 0.29-0.95]). No parallel differences were found between menthol and non-menthol methamphetamine-dependent smokers. The prevalence of Caucasian menthol smokers was significantly greater in the cocaine-dependent participants (37.2%) than in the methamphetamine-dependent participants (17.61%), (X(2)(1)=14.4, p<.001, OR=2.77 [95% CI:1.62-4.73]). Smoking cessation was not significantly associated with cigarette type for either cocaine- or methamphetamine-dependent participants. CONCLUSIONS: The present results suggest that mentholated cigarettes play a role in cocaine, but not methamphetamine, dependence.

Relationship of age to impulsivity and decision making: a baseline secondary analysis of a behavioral treatment study in stimulant use disorders.

Because stimulant use disorders remain prevalent across the lifespan, cognition is an important area of clinical care and research focus among aging adults with stimulant use disorders. This secondary analysis of a National Institute on Drug Abuse Clinical Trials Network study suggests that decision making, verbal learning/memory, executive function, and set shifting are important cognitive domains to screen clinically and treat in aging adults with stimulant use disorders. Some suggestions are made on how clinical treatment providers can practically use these results. An important direction for future research is the development of cognitively remediating treatments for impaired cognitive domains in aging adults with stimulant use disorders.

Frontal systems deficits in stimulant-dependent patients: evidence of pre-illness dysfunction and relationship to treatment response.

BACKGROUND: Frontal systems dysfunction is present in stimulant-dependent patients. However, it is unclear whether this dysfunction is a pre-morbid risk factor or stimulant-induced, is severe enough to be clinically relevant, and if it is relevant to treatment response. These questions were addressed using the Frontal Systems Behavior Scale (FrSBe), a reliable and valid self-report assessment of three neurobehavioral domains associated with frontal systems functioning (Apathy, Disinhibition, and Executive Dysfunction, summed for a Total), that assesses both pre- and post-morbid functioning, and has a specific cutoff for defining clinically significant abnormalities. METHOD: Six sites evaluating 12-step facilitation for stimulant abusers obtained the FrSBe from 180 methamphetamine- and/or cocaine-dependent participants. Dichotomous treatment response measures included self-reported stimulant use, stimulant urine drug screens, and treatment completion. RESULTS: A substantial percentage of participants retrospectively reported clinically significant neurobehavioral abnormalities prior to lifetime stimulant abuse initiation (e.g., 67.5% on FrSBe-Total) with a significant increase in the proportion reporting such abnormalities for current functioning (86% on FrSBe-Total; p<0.0001). Treatment response was significantly worse for participants with, relative to those without, clinically significant Disinhibition as measured by treatment non-completion (31.6% vs. 15.6%, OR=2.51) and self-reported stimulant use during treatment (40.5% vs. 16.7%, OR=3.40). CONCLUSION: These findings suggest that frontal systems dysfunction is present prior to stimulant-abuse onset and worsens with stimulant use. Disinhibition may be a prime target for intervention in stimulant-dependent individuals.

Osmotic release oral system methylphenidate prevents weight gain during a smoking-cessation attempt in adults with ADHD.

BACKGROUND: Adults with attention-deficit/hyperactivity disorder (ADHD) are at increased risk for both cigarette smoking and being overweight or obese. Although smoking cessation tends to result in weight increase, potentially initiating or exacerbating weight problems, adults with ADHD who are treated with osmotic release oral system methylphenidate (OROS-MPH) tend to lose weight. It is unclear how the use of OROS-MPH during a smoking-cessation attempt might affect the typical weight gain that accompanies cessation. METHOD: We examined changes in weight and hunger during a smoking-cessation attempt in 215 adults with ADHD who completed a multisite, randomized, controlled trial and were randomized to either OROS-MPH (n = 107) or placebo (n = 108) (NCT #00253747). Both groups also received open-label transdermal nicotine replacement and counseling. RESULTS: Participants who received OROS-MPH lost an average of 1.6% of their body weight during the 11-week study, whereas those who received placebo gained an average of 1.3% of their weight (p < .001). Hunger ratings were lower in the OROS-MPH group (M = 1.1, SD = 0.8) than in the placebo group (M = 1.6, SD = 0.9; p < .001). CONCLUSIONS: The use of OROS-MPH during a smoking-cessation attempt prevents weight gain in adults with ADHD who substantially reduce or quit smoking. The potential utility of OROS-MPH in individuals with ADHD who are attempting to quit smoking and for whom weight gain would be problematic warrants further research.

Preliminary evidence that adherence to counseling mediates the effects of pretreatment self-efficacy and motivation on outcome of a cessation attempt in smokers with ADHD.

BACKGROUND: Few studies have evaluated predictors of smoking cessation outcomes in smokers with attention-deficit/hyperactivity disorder (ADHD), which could help to improve suboptimal treatment outcomes in this population. The purpose of this study was to examine pretreatment thoughts about smoking abstinence (i.e., desire to quit, perceived difficulty quitting, and expected success in quitting) as predictors of smoking cessation outcomes in smokers with ADHD and to determine the extent to which treatment adherence mediates these relationships. METHODS: Participants were adult smokers with ADHD (n = 255), who were enrolled in a multisite smoking cessation study and received either osmotic-release oral system methylphenidate (OROS-MPH) or placebo in combination with transdermal nicotine replacement and brief cessation counseling. Bootstrapped logistic regression models were generated to test main effects of thoughts about abstinence on smoking cessation outcomes and to examine treatment adherence as a mediator of these relationships. RESULTS: Desire to quit and expected success in quitting, but not perceived difficulty quitting, predicted smoking cessation outcomes, as did all of the treatment adherence variables (i.e., percent sessions attended, counselor ratings of counseling adherence, and percent patch adherence). Counseling adherence partially mediated the relationship between smoking cessation outcomes and both pretreatment desire to quit and expected success. CONCLUSIONS: Smokers with ADHD who have higher self-efficacy (i.e., expected success) and motivation (i.e., desire) to quit are more adherent to smoking cessation counseling and have better smoking cessation outcomes. Additional research is needed to determine whether treatment-seeking smokers with ADHD would benefit from an intervention designed to increase self-efficacy and motivation to quit.

Pre-treatment change in a randomized trial with pregnant substance-abusing women in community-based outpatient treatment.

Participants in clinical trials of interventions for substance use frequently show substantial pre-treatment reductions in use. However, pre-treatment change has not been studied among pregnant women, a group with unique motivational characteristics. It is also not clear whether pre-treatment reduction in substance use can be clearly linked to research activities such as pre-treatment assessment, or if it is the result of more general factors such as the decision to seek treatment. Using an interrupted longitudinal design, we evaluated pre-treatment change among 148 pregnant women, all of whom had completed a clinical trial comparing motivational enhancement therapy to treatment as usual. When baseline period was compared to the period after randomization and before treatment, the change in substance use was substantial (dropping from an average of substance use on 30.5% of days during baseline to 16.7% of days during the pre-treatment phase; p<.001), and was greater in magnitude than change following initiation of study-related treatment. Further, this reduction was significant after controlling for a longitudinal time effect and did not apply to tobacco use. These findings suggest that change following pre-treatment research activities is independent of the decision to seek treatment and is present even among pregnant women, many of whom have already reduced their substance use. These findings also suggest the possible need for re-evaluation of the nature and causes of behavior change, as well as trial design, in clinical trials for substance abuse.

Subjective effects, misuse, and adverse effects of osmotic-release methylphenidate treatment in adolescent substance abusers with attention-deficit/hyperactivity disorder.

OBJECTIVE: Psychostimulants are effective treatments for attention-deficit/hyperactivity disorder (ADHD) but may be associated with euphoric effects, misuse/diversion, and adverse effects. These risks are perceived by some clinicians to be greater in substance-abusing adolescents relative to non-substance-abusing adults. The present study evaluates the subjective effects, misuse/diversion, and adverse effects associated with the use of osmotic-release oral system methylphenidate (OROS-MPH), relative to placebo, for treating ADHD in adolescents with a substance use disorder (SUD) as a function of substance use severity and compared these risks with those associated with the treatment of ADHD in adults without a non-nicotine SUD. METHOD: Datasets from two randomized placebo-controlled trials of OROS-MPH for treating ADHD, one conducted with 303 adolescents (13-18) with at least one non-nicotine SUD and one with 255 adult smokers (18-55), were analyzed. Outcome measures included the Massachusetts General Hospital Liking Scale, self-reported medication compliance, pill counts, and adverse events (AEs). RESULTS: Euphoric effects and misuse/diversion of OROS-MPH were not significantly affected by substance use severity. The euphoric effects of OROS-MPH did not significantly differ between the adolescent and adult samples. Adults rated OROS-MPH as more effective in treating ADHD, whereas adolescents reported feeling more depressed when taking OROS-MPH. The adolescents lost more pills relative to the adults regardless of treatment condition, which suggests the importance of careful medication monitoring. Higher baseline use of alcohol and cannabis was associated with an increased risk of experiencing a treatment-related AE in OROS-MPH, but baseline use did not increase the risk of serious AEs or of any particular category of AE and the adolescents did not experience more treatment-related AEs relative to the adults. CONCLUSIONS: With good monitoring, and in the context of substance abuse treatment, OROS-MPH can be safely used in adolescents with an SUD despite non-abstinence.

Impact of attention-deficit/hyperactivity disorder (ADHD) treatment on smoking cessation intervention in ADHD smokers: a randomized, double-blind, placebo-controlled trial.

OBJECTIVE: High smoking rates in adults with attention-deficit/hyperactivity disorder (ADHD) and nicotine's amelioration of ADHD suggest that effective ADHD treatment might facilitate abstinence in smokers with ADHD. The present study evaluated if using osmotic-release oral system methylphenidate (OROS-MPH) to treat ADHD enhances response to smoking cessation treatment in smokers with ADHD. METHOD: A randomized, double-blind, placebo-controlled, 11-week trial with a 1-month follow-up was conducted at 6 clinical sites between December 2005 and January 2008. Adults (aged 18-55 years) meeting DSM-IV criteria for ADHD and interested in quitting smoking were randomly assigned to OROS-MPH titrated to 72 mg/d (n = 127) or placebo (n = 128). All participants received brief weekly individual smoking cessation counseling for 11 weeks and 21 mg/d nicotine patches starting on the smoking quit day (day 27) through study week 11. Outcome measures included prolonged smoking abstinence and DSM-IV ADHD Rating Scale (ADHD-RS) score. RESULTS: Of 255 randomly assigned participants, 204 (80%) completed the trial. Prolonged abstinence rates, 43.3% and 42.2%, for the OROS-MPH and placebo groups, respectively, did not differ significantly (OR = 1.1; 95% CI, 0.63-1.79; P = .81). Relative to placebo, OROS-MPH evidenced a greater reduction in DSM-IV ADHD-RS score (P < .0001) and in cigarettes per day during the post-quit phase (P = .016). Relative to placebo, OROS-MPH increased blood pressure and heart rate to a statistically, but not clinically, significant degree (P < .05); medication discontinuation did not differ significantly between treatments. CONCLUSIONS: Treatment for ADHD did not improve smoking cessation success; OROS-MPH, relative to placebo, effectively treated ADHD and was safe and generally well tolerated in this healthy sample of adult ADHD smokers. TRIAL REGISTRATION: clinical trials.gov Identifier: NCT00253747.

External pressure, motivation, and treatment outcome among pregnant substance-using women.

The weight of evidence suggests that legal pressure to enter treatment facilitates retention. However, the extent to which such mandates (a) influence actual levels of substance use, or (b) also facilitate retention among pregnant women, is unclear. Associations between external pressure-defined as self-reported pressure to attend treatment under threat of incarceration, loss of child custody, and/or loss of subsidized housing--and the key outcomes of retention and substance use were therefore examined in a sample of 200 pregnant women receiving community-based substance abuse treatment. The role of external pressure was examined in a series of Cox and GEE regressions, which suggested that external pressure as measured at baseline was associated with decreased risk of dropout (Hazard Ratio=.47, p=.001) and fewer drug-positive urine tests throughout treatment and 12-week follow-up (OR=.48, p=.03). These differences did not appear to be the result of baseline differences between coerced and non-coerced participants in education, legal history, the presence or absence of a substance use disorder, employment, or motivation. The present findings extend the larger literature on external pressure by demonstrating effects on drug use as well as on retention, and among pregnant women.

Pes varus correction in Dachshunds using a hybrid external fixator.

OBJECTIVE: To describe surgical correction of pes varus deformity in Dachshunds by acute medial opening wedge osteotomy of the distal aspect of the tibia stabilized with a hybrid external skeletal fixator (HESF), and report clinical and radiographic outcomes. STUDY DESIGN: Multicenter, retrospective clinical study. ANIMALS: Immature Dachshunds (n=13) with pes varus deformity. METHODS: Limb function and lameness scores were assigned before and after surgery, and correction was determined visually at surgery. Tibiotarsal joint orientation (TTJO) and medial and lateral tibial cortex lengths, measured on radiographs of deformed and normal (when available) limbs, were compared before correction and after fixator removal. RESULTS: Pes varus deformities (n=14) were corrected; 93% had good to excellent clinical outcome. None of the dogs had a normal preoperative gait. Mean TTJO of abnormal and normal tibiae before surgery were 29 degrees varus (median, 28 degrees), and 12 degrees valgus (median, 12 degrees). Angular correction ranged from 20 degrees to 51 degrees (mean, 36+/-8 degrees; median, 36 degrees). Mean TTJO after fixator removal was 7 degrees valgus (median, 7 degrees). Two dogs had minor transient postoperative complications whereas 3 had major complications; only 1 of which was resolved. CONCLUSIONS: Pes varus deformity in Dachshunds can be corrected by acute medial opening wedge osteotomy of the distal aspect of the tibia stabilized by HESF. Technique modifications are needed to improve correction precision. CLINICAL RELEVANCE: Visual inspection of limb alignment during surgery resulted in good to excellent clinical outcomes; however, 91% of tibiae were under- or overcorrected (mean, 6 degrees; median, 5 degrees). Limb alignment should be based on evaluation of immediate postoperative TTJO measurements, not solely on intraoperative visual assessment.