Bupropion and Naltrexone in Methamphetamine Use Disorder.

BACKGROUND: The use of naltrexone plus bupropion to treat methamphetamine use disorder has not been well studied. METHODS: We conducted this multisite, double-blind, two-stage, placebo-controlled trial with the use of a sequential parallel comparison design to evaluate the efficacy and safety of extended-release injectable naltrexone (380 mg every 3 weeks) plus oral extended-release bupropion (450 mg per day) in adults with moderate or severe methamphetamine use disorder. In the first stage of the trial, participants were randomly assigned in a 0.26:0.74 ratio to receive naltrexone-bupropion or matching injectable and oral placebo for 6 weeks. Those in the placebo group who did not have a response in stage 1 underwent rerandomization in stage 2 and were assigned in a 1:1 ratio to receive naltrexone-bupropion or placebo for an additional 6 weeks. Urine samples were obtained from participants twice weekly. The primary outcome was a response, defined as at least three methamphetamine-negative urine samples out of four samples obtained at the end of stage 1 or stage 2, and the weighted average of the responses in the two stages is reported. The treatment effect was defined as the between-group difference in the overall weighted responses. RESULTS: A total of 403 participants were enrolled in stage 1, and 225 in stage 2. In the first stage, 18 of 109 participants (16.5%) in the naltrexone-bupropion group and 10 of 294 (3.4%) in the placebo group had a response. In the second stage, 13 of 114 (11.4%) in the naltrexone-bupropion group and 2 of 111 (1.8%) in the placebo group had a response. The weighted average response across the two stages was 13.6% with naltrexone-bupropion and 2.5% with placebo, for an overall treatment effect of 11.1 percentage points (Wald z-test statistic, 4.53; P<0.001). Adverse events with naltrexone-bupropion included gastrointestinal disorders, tremor, malaise, hyperhidrosis, and anorexia. Serious adverse events occurred in 8 of 223 participants (3.6%) who received naltrexone-bupropion during the trial. CONCLUSIONS: Among adults with methamphetamine use disorder, the response over a period of 12 weeks among participants who received extended-release injectable naltrexone plus oral extended-release bupropion was low but was higher than that among participants who received placebo. (Funded by the National Institute on Drug Abuse and others; ADAPT-2 ClinicalTrials.gov number, NCT03078075.).

Stigma towards opioid use disorder in primary care remain a barrier to integrating software-based measurement based care.

BACKGROUND: Opioid use disorder (OUD) is a deadly illness that remains undertreated, despite effective pharmacological treatments. Barriers, such as stigma, treatment affordability, and a lack of training and prescribing within medical practices result in low access to treatment. Software-delivered measurement-based care (MBC) is one way to increase treatment access. MBC uses systematic patient symptom assessments to inform an algorithm to support clinicians at critical decision points. METHOD: Focus groups of faculty clinicians (N = 33) from 3 clinics were conducted to understand perceptions of OUD diagnosis and treatment and whether a computerized MBC model might assist with diagnosis and treatment. Themes from the transcribed focus groups were identified in two phases: (1) content analysis focused on uncovering general themes; and (2) systematic coding and interpretation of the data. RESULTS: Analysis revealed six major themes utilized to develop the coding terms: "distinguishing between chronic pain and OUD," "current practices with patients using prescribed or illicit opioids or other drugs," "attitudes and mindsets about providing screening or treatment for OUD in your practice," "perceived resources needed for treating OUD," "primary care physician role in patient care not specific to OUD," and "reactions to implementation of proposed clinical decision support tool." CONCLUSION: Results revealed that systemic and attitudinal barriers to screening, diagnosing, and treating OUD continue to persist. Providers tended to view the software-based MBC program favorably, indicating that it may be a solution to increasing accessibility to OUD treatment; however, further interventions to combat stigma would likely be needed prior to implementation of these programs. TRIAL REGISTRATION: ClinicalTrials.gov; NCT04059016; 16 August 2019; retrospectively registered; https://clinicaltrials.gov/ct2/show/NCT04059016 .

Moderation of buprenorphine therapy for cocaine dependence efficacy by variation of the Prodynorphin gene.

PURPOSE: The aim of this secondary analysis was to identify prodynorphin (PDYN) genetic markers moderating the therapeutic response to treatment of cocaine dependence with buprenorphine/naloxone (Suboxone®; BUP). METHODS: Cocaine-dependent participants (N = 302) were randomly assigned to a platform of injectable, extended-release naltrexone (XR-NTX) and one of three daily medication arms: 4 mg BUP (BUP4), 16 mg BUP (BUP16), or placebo (PLB) for 8 weeks (Parent Trial Registration: Protocol ID: NIDA-CTN-0048, Clinical Trials.gov ID: NCT01402492). DNA was obtained from 277 participants. Treatment response was determined from weeks 3 to 7 over each 1-week period by the number of cocaine-positive urines per total possible urines. RESULTS: In the cross-ancestry group, the PLB group had more cocaine-positive urines than the BUP16 group (P = 0.0021). The interactions of genetic variant × treatment were observed in the rs1022563 A-allele carrier group where the BUP16 group (N = 35) had fewer cocaine-positive urines (P = 0.0006) than did the PLB group (N = 26) and in the rs1997794 A-allele carrier group where the BUP16 group (N = 49) had fewer cocaine-positive urines (P = 0.0003) than did the PLB group (N = 58). No difference was observed in the rs1022563 GG or rs1997794 GG genotype groups between the BUP16 and PLB groups. In the African American-ancestry subgroup, only the rs1022563 A-allele carrier group was associated with treatment response. CONCLUSION: These results suggest that PDYN variants may identify patients who are best suited to treatment with XR-NTX plus buprenorphine for cocaine use disorder pharmacotherapy.

The Stimulant Selective Severity Assessment: A replication and exploratory extension of the Cocaine Selective Severity Assessment.

BACKGROUND: Cocaine and methamphetamine have similar withdrawal symptoms and many individuals concurrently use both substances; however, no measures concurrently assess withdrawal from multiple stimulants. OBJECTIVES: This study's aim was to explore the Stimulant Selective Severity Assessment (SSSA), a modified version of the Cocaine Selective Severity Assessment (CSSA), in a sample of stimulant users to determine if it can assess withdrawal symptoms in users of one or more stimulants. METHODS: Baseline data were analyzed from the STimulant Reduction Intervention using Dosed Exercise trial, a multisite randomized clinical trial that evaluated exercise versus health education on drug use outcomes in individuals with stimulant use disorders. Data were analyzed for internal consistency, construct validity, and scale dimensionality. RESULTS: Internal consistency for the full sample was good (α = 0.81; N = 302), with similar alphas in Cocaine (0.81; n = 177) and Cocaine/Other Stimulant (0.82; n = 92) groups, but with much lower alpha for the group without cocaine use (Other Stimulant, i.e., primarily methamphetamine, α = 0.66; n = 32). Support for construct validity was evidenced by significant positive correlations (r = 0.17 to 0.67) with measures of stimulant craving, depressive symptoms, and pain. Four factors were revealed. Conclusions/Importance: The Stimulant Selective Severity Assessment is a new measure that can be used to assess withdrawal symptoms in users of cocaine or cocaine plus methamphetamine, but it should not be administered to users of methamphetamine only.

Baseline medical comorbidities in adults randomized in the STRIDE trial for psychostimulant use disorders.

BACKGROUND AND OBJECTIVES: Rates of medical illnesses may be higher among individuals with substance use disorders, complicating their care. This study aimed to expand the understanding of other medical conditions in treatment-seeking adults with stimulant use disorder (SUD) using data from Stimulant Reduction Intervention using Dose Exercise (STRIDE), a randomized, multisite trial investigating exercise augmentation of treatment as usual. METHODS: Utilizing STRIDE baseline data, we examined demographic and clinical characteristics based on the number of self-reported diagnosed medical conditions among participants meeting eligibility criteria (passing medical screening exam and maximal exercise test, non-opioid dependent, no concomitant beta blocker, or opioid replacement therapy). RESULTS: The majority (59%) of study participants (N = 302, mean age all participants = 39 years) did not report any history of other medical problems. Those with two or more conditions were older (mean age 46 years), reported more pain and worse physical functioning, and more psychiatric disorders (average 1.44). Hypertension was more common among participants with cocaine use disorders only (present in 16%) and liver disease was more common in those with cocaine plus other stimulant use disorders (present in 7%). CONCLUSION AND SCIENTIFIC SIGNIFICANCE: In this sample, patients with SUD were in surprisingly good health. A subpopulation had an overall higher burden of illness with worsened physical and psychiatric functioning. Provision of coordinated care may optimize treatment outcomes for patients based on medical comorbidity burden as well as type of drug abused, although these conclusions should be considered preliminary as they are based on self-reported data.

Decision-making processes as predictors of relapse and subsequent use in stimulant-dependent patients.

BACKGROUND: Decision-making processes have been posited to affect treatment outcome in addicted patients. OBJECTIVE: The present multi-site study assessed whether two measures of decision-making predicted relapse and subsequent use in stimulant-dependent patients. METHODS: A total of 160 methamphetamine- or cocaine-dependent patients participating in a multi-site clinical trial evaluating a modified 12-step facilitation intervention for stimulant-dependent patients (STAGE-12) were assessed. Decision-making processes of risk and delay (Iowa Gambling Task [IGT]) and response reversal (Wisconsin Card Sorting Task [WCST]) were obtained shortly after treatment admission followed by assessment of stimulant use over the next six months. The relationships of the IGT and WCST (Perseverative Errors) with relapse (yes/no) and days of stimulant use during the 6-month period following post-randomization were evaluated. RESULTS: Performance on the IGT and WCST did not significantly predict relapse status or time to relapse. Unexpectedly, worse performance on the IGT was associated with a fewer number of stimulant use days (p = 0.001). In contrast, worse performance on the WCST (more perseverative errors) was associated with a greater number of stimulant use days (p = 0.0003). The predictive effects of perseverative errors on subsequent use were confined to methamphetamine-dependent and Minority participants. CONCLUSIONS: Decision-making processes, as measured in the current study, do not uniformly predict relapse or subsequent use. A decrease in the salience attribution of non-drug reinforcers may explain the positive relationship between IGT performance and post-relapse use. More comprehensive and global measures of impulsiveness may better assess relapse risk and use.

Depressive Symptoms and Associated Clinical Characteristics in Outpatients Seeking Community-Based Treatment for Alcohol and Drug Problems.

BACKGROUND: Comorbid psychiatric and substance use disorders are common and associated with poorer treatment engagement, retention, and outcomes. This study examines the presence of depressive symptoms and the demographic and clinical correlates in a diverse sample of substance abuse treatment seekers to better characterize patients with co-occurring depressive symptoms and substance use disorders and understand potential treatment needs. METHODS: Baseline data from a randomized clinical effectiveness trial of a computer-assisted, Web-delivered psychosocial intervention were analyzed. Participants (N = 507) were recruited from 10 geographically diverse outpatient drug treatment programs. Assessments included the self-report Patient Health Questionnaire, and measures of coping strategies, social functioning, physical health status, and substance use. RESULTS: One fifth (21%; n = 106) of the sample screened positive for depression; those screening positive for depression were significantly more likely to screen positive for anxiety (66.9%) and posttraumatic stress disorder (PTSD; 42.9%). After controlling for anxiety and PTSD symptoms, presence of depressive symptoms remained significantly associated with fewer coping strategies (P = .001), greater impairment in social adjustment (P < .001), and poorer health status (P < .001), but not to days of drug use in the last 90 days (P = .14). CONCLUSIONS: Depression is a clinically significant problem among substance abusers, and, in this study, patients who screened positive for depression were more likely to have co-occurring symptoms of anxiety and PTSD. Additionally, the presence of depressive symptoms was associated with fewer coping strategies and poorer social adjustment. Coping skills are a significant predictor of addiction outcomes, and it may be especially important to screen for and enhance coping among depressed patients. Evidence-based interventions that target coping skills and global functioning among substance abusers with depressive symptoms may be important adjuncts to usual treatment.

The Use of Technology in Participant Tracking and Study Retention: Lessons Learned From a Clinical Trials Network Study.

BACKGROUND: The growing use of newer communication and Internet technologies, even among low-income and transient populations, require research staff to update their outreach strategies to ensure high follow-up and participant retention rates. This paper presents the views of research assistants on the use of cell phones and the Internet to track participants in a multisite randomized trial of substance use disorder treatment. METHODS: Preinterview questionnaires exploring tracking and other study-related activities were collected from 21 research staff across the 10 participating US sites. Data were then used to construct a semistructured interview guide that, in turn, was used to interview 12 of the same staff members. The questionnaires and interview data were entered in Atlas.ti and analyzed for emergent themes related to the use of technology for participant-tracking purposes. RESULTS: Study staff reported that most participants had cell phones, despite having unstable physical addresses and landlines. The incoming call feature of most cell phones was useful for participants and research staff alike, and texting proved to have additional benefits. However, reliance on participants' cell phones also proved problematic. Even homeless participants were found to have access to the Internet through public libraries and could respond to study staff e-mails. Some study sites opened generic social media accounts, through which study staff sent private messages to participants. However, the institutional review board (IRB) approval process for tracking participants using social media at some sites was prohibitively lengthy. Internet searches through Google, national paid databases, obituaries, and judiciary Web sites were also helpful tools. CONCLUSIONS: Research staff perceive that cell phones, Internet searches, and social networking sites were effective tools to achieve high follow-up rates in drug abuse research. Studies should incorporate cell phone, texting, and social network Web site information on locator forms; obtain IRB approval for contacting participants using social networking Web sites; and include Web searches, texting, and the use of social media in staff training as standard operating procedures.

Comorbidities and race/ethnicity among adults with stimulant use disorders in residential treatment.

Comorbid physical and mental health problems are associated with poorer substance abuse treatment outcomes; however, little is known about these conditions among stimulant abusers at treatment entry. This study compared racial and ethnic groups on baseline measures of drug use patterns, comorbid physical and mental health disorders, quality of life, and daily functioning among cocaine and stimulant abusing/dependent patients. Baseline data from a multi-site randomized clinical trial of vigorous exercise as a treatment strategy for a diverse population of stimulant abusers (N=290) were analyzed. Significant differences between groups were found on drug use characteristics, stimulant use disorders, and comorbid mental and physical health conditions. Findings highlight the importance of integrating health and mental health services into substance abuse treatment and could help identify potential areas for intervention to improve treatment outcomes for racial and ethnic minority groups.

Optimal neurocognitive, personality and behavioral measures for assessing impulsivity in cocaine dependence.

BACKGROUND: Impulsivity may underlie the poor treatment retention and high relapse rates observed in cocaine-dependent persons. However, observed differences in measures of impulsivity between cocaine-dependent and healthy control participants often do not reach clinical significance, suggesting that the clinical relevance of these differences may be limited. OBJECTIVES: To examine which measures of impulsivity (i.e. self-report impulsivity, self-report personality, neurocognitive testing) best distinguish cocaine-dependent and healthy control participants (i.e. showing differences at least 1.5 standard deviations [SD] from controls). Optimal measures were considered to demonstrate sufficient classification accuracy. METHODS: Sixty-five recently abstinent cocaine-dependent and 25 healthy control participants were assessed using select neurocognitive tests and self-report questionnaires including the NEO Personality Inventory-Revised (NEO-PI-R), Temperament and Character Inventory (TCI), Barratt Impulsiveness Scale (BIS-11a), and the Frontal Systems Behavior Scale (FrSBe). RESULTS: When corrected for years of education and gender, neurocognitive measures did not demonstrate clinically significant differences between cocaine-dependent and control participants. The personality measures TCI Purposefulness and Congruent Second Nature and NEO-PI-R Impulsiveness, and the self-rating measures FrSBe Disinhibition and BIS-11 Motor Impulsivity and Total successfully identified clinically meaningful elevations in impulsivity within cocaine-dependent participants (>1.5 SDs from controls). Furthermore, these measures achieved 84-93% accuracy in discriminating cocaine-dependent from control participants. CONCLUSION: Clinically significant neurocognitive impairment in cocaine-dependent participants was not observed in this sample. As the BIS-11 or FrSBe are brief to administer, accurate, and have been shown to predict treatment retention and relapse, these measures appear to be optimal, relative to the personality measures, for examining trait impulsivity in cocaine dependence.

Family discord is associated with increased substance use for pregnant substance users.

Childhood abuse and partner violence are associated with prenatal substance abuse, but the potential impact of current family discord, which reflects broader family relationships and encompasses problems less severe than violence, has had little evaluation in pregnant substance users. Using data from 196 pregnant substance users participating in a NIDA Clinical Trials Network randomized clinical trial, we examined the relationship of baseline family discord to substance use and treatment session attendance. Family discord was assessed using items from the family composite of the Addiction Severity Index. Substance use was assessed by the Substance Use Calendar and urine drug screens (UDS). Assessments were weekly for four weeks and at two- and four-month post-randomization. Women with family discord were more likely to report living with a problematic substance user, reported a higher percentage of substance use days throughout each study phase, had a greater proportion of positive UDS over the four-month study period, and attended more weeks of treatment during the first month. Specific treatment interventions targeting pregnant women with family discord may be warranted.

Research staff training in a multisite randomized clinical trial: Methods and recommendations from the Stimulant Reduction Intervention using Dosed Exercise (STRIDE) trial.

BACKGROUND: Descriptions of and recommendations for meeting the challenges of training research staff for multisite studies are limited despite the recognized importance of training on trial outcomes. The STRIDE (STimulant Reduction Intervention using Dosed Exercise) study is a multisite randomized clinical trial that was conducted at nine addiction treatment programs across the United States within the National Drug Abuse Treatment Clinical Trials Network (CTN) and evaluated the addition of exercise to addiction treatment as usual (TAU), compared to health education added to TAU, for individuals with stimulant abuse or dependence. Research staff administered a variety of measures that required a range of interviewing, technical, and clinical skills. PURPOSE: In order to address the absence of information on how research staff are trained for multisite clinical studies, the current manuscript describes the conceptual process of training and certifying research assistants for STRIDE. METHODS: Training was conducted using a three-stage process to allow staff sufficient time for distributive learning, practice, and calibration leading up to implementation of this complex study. RESULTS: Training was successfully implemented with staff across nine sites. Staff demonstrated evidence of study and procedural knowledge via quizzes and skill demonstration on six measures requiring certification. Overall, while the majority of staff had little to no experience in the six measures, all research assistants demonstrated ability to correctly and reliably administer the measures throughout the study. CONCLUSIONS: Practical recommendations are provided for training research staff and are particularly applicable to the challenges encountered with large, multisite trials.

Characteristics of Mexican and Mexican American adolescents in treatment for "cheese" heroin use.

Clinical and cultural characteristics of Hispanic adolescent heroin users are not well described. The current exploratory study was conducted to describe a sample of in-treatment Hispanic adolescents with opioid dependence, specifically, cheese heroin. Mexican and Mexican American adolescents with heroin dependence (N = 72) in three treatment programs were interviewed and completed self-report measures. Participants reported, on average, first using cheese heroin at age 13.5 years and daily use at age 14.2 years. The majority (74%) reported a previous overdose. Adolescents being raised by caregivers other than both biological parents, who used drugs with relatives, and whose immediate family members have documentation to be in the United States fared worse on several indicators of drug use severity and other risky behaviors. The self-reported brief time period from first use to daily use strongly suggests the need for early prevention efforts. Additional research is needed to add to these preliminary results and inform prevention efforts.

A randomized control trial of a combined community health worker and re-entry intervention for people with HIV recently released from jail who use substances.

INTRODUCTION: People with human immunodeficiency virus (HIV; PWH) who use substances are disproportionately involved in the criminal justice system. While HIV viral suppression typically improves during incarceration, these gains are frequently lost after release. We evaluated the impact of a combined intervention (formerly incarcerated community health workers [CHW] plus a re-entry organization; CHW+) on postrelease HIV- and substance use-related outcomes. METHODS: We conducted a pilot randomized controlled trial of a CHW+ for PWH who use substances, within 30 days of release from a large southern, urban jail. Between February 2019 and August 2021, participants were recruited, enrolled, and randomized to treatment as usual (TAU; passive referral to care) or CHW+. Follow up study visits occurred at 3, 6, and 12 months. The primary outcome was HIV VL at 6 months; secondary outcomes included 6-month urinary toxicology and high-risk substance use at 12 months. RESULTS: A total of 31 participants were enrolled who were primarily male (n = 24; 77 %), Black (n = 22; 71 %), unemployed (n = 23; 74.2 %), had unstable housing (n = 18; 58 %), had food insecurity (n = 14; 45 %), and reported their drug of choice was stimulants (n = 24; 77 %). The study identified no significant difference in HIV VL suppression at 6 months (20 % v. 37 %; [CHW+ v. TAU], p = 0.61). We observed improved substance use outcomes in CHW+ v. TAU, including fewer positive urinary toxicology screens for stimulants (40 % v. 100 %; p = 0.01) and a trend toward less high-risk substance use (30 % v. 43 %). The CHW+ group met more basic needs, such as food security [+32 % v. +11 %], housing security [+52 % v. -7 %] and full-time employment [+20 % v. +5 %] compared to TAU. CONCLUSIONS: PWH who use substances assigned to a combined intervention of CHW+ after jail release did not achieve higher rates of HIV VL suppression than TAU; however, they had improved substance use outcomes and met more basic subsistence needs. Results highlight the potential of culturally informed interventions to address the competing needs of PWH who use substances after release from jail and call for further development of innovative solutions to successfully bridge to HIV care in the community.

Descriptive characteristics and cluster analysis of male veteran hazardous drinkers in an alcohol moderation intervention.

Current efforts underway to develop the fifth edition of the Diagnostic and Statistical Manual (DSM-5) have reignited discussions for classifying the substance use disorders. This study's aim was to contribute to the understanding of abusive alcohol use and its validity as a diagnosis. Cluster analysis was used to identify relatively homogeneous groups of hazardous, nondependent drinkers by using data collected from the Prevention and Treatment of Hypertension Study (PATHS), a multisite trial that examined the ability of a cognitive-behavioral-based alcohol reduction intervention, compared to a control condition, to reduce alcohol use. Participants for this study (N = 511) were male military veterans. Variables theoretically associated with alcohol use (eg, demographic, tobacco use, and mental health) were used to create the clusters and a priori, empirically based external criteria were used to assess discriminant validity. Bivariate correlations among cluster variables were generally consistent with previous findings in the literature. Analyses of internal and discriminant validity of the identified clusters were largely nonsignificant, suggesting meaningful differences between clusters could not be identified. Although the typology literature has contributed supportive validity for the alcohol dependence diagnosis, this study's results do not lend supportive validity for the construct of alcohol abuse.

Design of NIDA CTN Protocol 0047: screening, motivational assessment, referral, and treatment in emergency departments (SMART-ED).

BACKGROUND: Medical settings such as emergency departments (EDs) present an opportunity to identify and provide services for individuals with substance use problems who might otherwise never receive any form of assessment, referral, or intervention. Although screening, brief intervention, and referral to treatment models have been extensively studied and are considered effective for individuals with alcohol problems presenting in EDs and other medical settings, the efficacy of such interventions has not been established for drug users presenting in EDs. OBJECTIVES: This article describes the design of a NIDA Clinical Trials Network protocol testing the efficacy of an screening, brief intervention, and referral to treatment model in medical EDs, highlighting considerations that are pertinent to the design of other studies targeting substance use behaviors in medical treatment settings. METHODS: The protocol is described, and critical design decisions are discussed. RESULTS: Design challenges included defining treatment conditions, study population, and site characteristics; developing the screening process; choosing the primary outcome; balancing brevity and comprehensiveness of assessment; and selecting the strategy for statistical analysis. CONCLUSION: Many of the issues arising in the design of this study will be relevant to future studies of interventions for addictions in medical settings. SCIENTIFIC SIGNIFICANCE: Optimal trial design is critical to determining how best to integrate substance abuse interventions into medical care.

Reaching nontreatment-seeking cannabis users: Testing an extended marijuana check-up intervention.

Some adult cannabis users report negative consequences of use but do not seek treatment. Nonjudgmental, brief interventions incorporating motivational interviewing techniques may be able to reach users who otherwise would not seek treatment and increase their motivation to change use. Previous studies have shown brief interventions with this population are efficacious in reducing use, but the absolute amount of change has not clearly translated into meaningful reductions in associated negative consequences. The current study used a marijuana check-up (MCU) model to attract nontreatment-seeking adults who used cannabis at levels that may have caused negative consequences. The study randomly assigned participants to 2-session (n = 93) and 6-session (n = 93) versions of the intervention and followed them for 12 months. The study designed the extended 6-session condition to build on the efficacy of the previously tested 2-session intervention. The study hypothesized that the opportunity to continue to consider the consequences of cannabis use would have the greatest impact on those who were in earlier stages of readiness for change. We used cognitive behavioral techniques to assist with change efforts when indicated. Results showed significant reductions in the frequency and daily duration of cannabis use at all follow-ups in both intervention conditions. The extended 6-session condition produced greater change only on a measure of the number of periods of the day in which cannabis was used. Reductions in dependence symptoms and problems related to cannabis use occurred in both conditions, but there was no effect of intervention condition. Participants who were less ready to make changes at the outset decreased use and negative consequences the least. Results suggested that some benefit of the extended session format of the check-up in reducing daily use, but the lack of a corresponding reduction in consequences suggested that the original 2-session MCU may be more cost effective.

Creation of an algorithm for clinical decision support for treatment of opioid use disorder with buprenorphine in primary care.

BACKGROUND: The treatment capacity for opioid use disorder (OUD) lags far behind the number of patients in need of treatment. Capacity is limited, in part, by the limited number of physicians who offer office based OUD treatment with buprenorphine. Measurement based care (MBC) has been proposed as a means to support primary care physicians in treating OUD. Here, we propose a set of measures and a clinical decision support algorithm to provide MBC for the treatment of OUD. METHODS: We utilized literature search and expert consensus to identify measures for universal screening and symptom tracking. We used expert consensus to create the clinical decision support algorithm. RESULTS: The Tobacco, Alcohol, Prescription medication, and other Substance use (TAPS) tool was selected as the best published measure for universal screening in primary care. No published measure was identified as appropriate for symptom tracking or medication adherence; therefore, we created the OUD Symptom Checklist from the DSM-5 criteria for OUD and the Patient Adherence Questionnaire for Opioid Use Disorder Treatment (PAQ-OUD) to assess medication adherence. We developed and present a clinical decision support algorithm to provide direct guidance regarding treatment interventions during the first 12 weeks of buprenorphine treatment. CONCLUSION: Creation of these tools is the necessary first step for implementation of MBC for the treatment of OUD with buprenorphine in primary care. Further work is needed to test the feasibility and acceptability of these tools. Trial Registration ClinicalTrials.gov; NCT04059016; 16 August 2019; retrospectively registered; https://clinicaltrials.gov/ct2/show/NCT04059016.

Treating cannabis use disorder: Exploring a treatment as needed model with 34-month follow-up.

Research has demonstrated that motivational enhancement (MET) and cognitive behavioral therapy (CBT) are some of the most effective interventions for adults with cannabis use disorder (CUD). As few as two sessions of combined MET and CBT has produced abstinence and reductions in cannabis use greater than delayed treatment controls. Despite their efficacy, outcomes in previous studies yielded abstinence rates from cannabis in the range of 20-30% at follow-ups of 6 to 12 months, and CUD remained a chronic condition for many. Additional models of providing treatment "as needed" (PRN), rather than as a single fixed-dose, are necessary to meet the different needs of adults with CUD and reengage those who do not respond to treatment initially or who relapse later. In the current study, 87 adults who met DSM-IV criteria for cannabis dependence were randomly assigned to receive either a fixed-dose of nine sessions of MET/CBT or to a PRN condition that provided a smaller initial dose of treatment, but allowed repeated access to treatment for 28 months. Cannabis use and associated problems were assessed every six months throughout a 34-month period. More than one-third of participants in the PRN condition accessed additional treatment episodes, but the total number of treatment sessions that participants utilized was comparable across conditions. Both treatments yielded significant reductions in cannabis use and associated problems at each follow-up. Contrary to hypotheses, the PRN condition did not yield better outcomes at the longer-term follow-ups. The fixed-dose condition produced greater rates of abstinence at the first follow-up, but otherwise there were no between group differences in outcomes. Future studies should test active approaches to reengaging participants with treatment when initial outcomes are less than optimal.