Overseen ByTony P George, MD., FRCPC
Age: 18 - 65
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: Centre for Addiction and Mental Health
Must be taking: Antidepressants
Disqualifiers: Alcohol, Illicit substances, Suicidal, Psychotic, Bipolar, others
No Placebo Group
Trial Summary
What is the purpose of this trial?The prevalence of major depressive disorder (MDD) is \~5.0%, and rates of co-occurring SUDs in these patients approach 40-50%. Specifically, rates of co-morbid cannabis use disorder (CUD) in patients with MDD are elevated 2-3 fold compared to 2.9% in the general population, and is associated with poorer treatment outcomes and impaired cognitive and psychosocial functioning in comparison to MDD patients without CUD. Most studies of cannabis use in MDD are cross-sectional in design, and therefore causal relationships are unclear. This study investigates the effects of cannabis abstinence over a 28-day period in patients with MDD with co-occurring CUD using a randomized controlled design, namely contingent reinforcement.
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications, but it requires that you have been on a stable dose of antidepressant medication for at least three months before joining.
What data supports the effectiveness of the treatment Contingency Management for cannabis abstinence in depression?
Research shows that Contingency Management (CM), which rewards people for staying off cannabis, can help reduce cannabis use and achieve abstinence, especially in those with mental health issues like depression. Studies found that CM was effective in improving outcomes for people with cannabis use disorder and co-occurring mental health disorders, suggesting it could be beneficial for those with depression.
12345Is contingency management a safe treatment for cannabis abstinence in humans?
Contingency management, which involves providing rewards for abstaining from cannabis, has been used safely in various studies to help people reduce or stop cannabis use. While it is effective in promoting abstinence, the main concerns are related to its cost and the need for proper training to implement it effectively.
12346How does cannabis abstinence differ from other treatments for depression?
Cannabis abstinence for depression is unique because it focuses on stopping cannabis use as a way to improve depressive symptoms, unlike traditional treatments that often involve medication or therapy directly targeting depression. This approach is based on the idea that reducing or eliminating cannabis use can lead to better mental health outcomes, especially for those with co-occurring cannabis use disorder and depression.
24789Eligibility Criteria
This trial is for adults aged 18-55 with Major Depressive Disorder and co-occurring moderate to severe Cannabis Use Disorder. They must be on stable antidepressant medication for three months, have an IQ of 80 or above, and show motivation. Excluded are those with bipolar disorder, significant head injury, other substance abuse (except nicotine/caffeine), psychotic disorders, or current suicidal/homicidal thoughts.Inclusion Criteria
Participants must have a Hamilton Depression Rating Scale (HDRS-17) at baseline assessment in the range of 12-25
Participants must meet SCID for DSM-5 diagnostic criteria for Major Depressive Disorder
I have been on a stable dose of antidepressants for at least three months.
+5 more
Exclusion Criteria
Participants with a psychotic disorder diagnosis (e.g. schizoaffective disorder, major depression with psychotic features) as determined by the SCID
Participants who meet criteria for substance use disorder of alcohol or other illicit substances within the past 6 months (with the exception of cannabis, nicotine, or caffeine)
Participants who meet SCID for DSM-5 diagnostic criteria for Bipolar Disorder
+5 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Treatment
Participants undergo a 28-day cannabis abstinence period with contingent or non-contingent reinforcement interventions
4 weeks
Weekly visits (in-person or virtual)
Follow-up
Participants are monitored for changes in depressive, anxiety, and sleep symptoms, as well as cognitive outcomes
4 weeks
2 visits (in-person)
Participant Groups
The study examines the impact of stopping cannabis use for 28 days in patients with depression who also frequently use cannabis. Participants will either receive rewards for abstaining from cannabis (Contingency Reinforcement) or not (Non-Contingency Reinforcement), to see if this affects their depression symptoms and cognitive function.
2Treatment groups
Experimental Treatment
Group I: Non-Contingency Reinforcement GroupExperimental Treatment1 Intervention
Subjects assigned to the NCR group with self-reported abstinence verified by urinary THC-COOH level \<20 ng/ml will not receive contingency monetary reinforcement at Day 28 of the study.
Group II: Contingency Reinforcement GroupExperimental Treatment1 Intervention
Subjects assigned to the CR group with self-reported abstinence verified by urinary THC-COOH level \<20 ng/ml will receive contingency monetary reinforcement at Day 28 of the study.
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Centre for Addiction and Mental HealthToronto, Canada
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Who Is Running the Clinical Trial?
Centre for Addiction and Mental HealthLead Sponsor
References
A randomized trial adapting contingency management targets based on initial abstinence status of cocaine-dependent patients. [2021]Contingency management (CM) reduces drug use, but questions remain regarding optimal targets and magnitudes of reinforcement. We evaluated the efficacy of CM reinforcing attendance in patients who initiated treatment with cocaine-negative samples, and of higher magnitude abstinence-based CM in patients who began treatment positive.
Contingency Management for Treatment of Cannabis Use Disorder in Co-Occurring Mental Health Disorders: A Systematic Review. [2023]Amongst individuals with a mental health disorder, a comorbid diagnosis of cannabis use disorder (CUD) is associated with numerous adverse consequences, including more severe symptom profiles, poorer treatment response, and reduced psychosocial functioning. Contingency management (CM), a method to specifically reinforce target behavior attainment (e.g., substance use abstinence), may provide an effective intervention in treating cannabis use in patients with a dual diagnosis of CUD and a mental health disorder. A systematic search examining the effects of CM on cannabis use, clinical, cognitive, and psychosocial outcomes in patients with a mental health disorder on PubMed, PsycINFO, and EMBASE databases up to November 2022 was performed. Six studies met inclusion criteria for our review. We found CM to be efficacious in producing cannabis use reductions and abstinence amongst individuals with a psychotic-spectrum or major depressive disorder. Additional longitudinal studies with larger sample sizes, other psychiatric populations, and longer follow-up periods are needed to evaluate the sustained effects of CM.
Combining cognitive behavioral therapy and contingency management to enhance their effects in treating cannabis dependence: less can be more, more or less. [2021]To evaluate reciprocal enhancement (combining treatments to offset their relative weaknesses) as a strategy to improve cannabis treatment outcomes. Contingency management (CM) with reinforcement for homework completion and session attendance was used as a strategy to enhance cognitive-behavioral therapy (CBT) via greater exposure to skills training; CBT was used as a strategy to enhance durability of CM with rewards for abstinence.
Abstinence rates following behavioral treatments for marijuana dependence. [2022]Previous studies have noted particular difficulty in achieving abstinence among those who are marijuana dependent. The present study employed a dismantling design to determine whether adding contingency management (ContM) to motivational enhancement therapy plus cognitive behavioral therapy (MET+CBT), an intervention used in prior studies of treatment for marijuana dependence, would enhance abstinence outcomes. 240 marijuana dependent participants were recruited via advertisements and assigned to either MET+CBT, ContM-only, MET+CBT+ContM, or to a case-management control condition. All interventions involved 9 weekly 1-h sessions, except for the ContM-only condition whose sessions lasted about 15 min. ContM provided reinforcement for marijuana-free urine specimens, in the form of vouchers redeemable for goods or services. Follow-up data were collected at posttreatment and at 3-month intervals for 1 year. The two ContM conditions had superior abstinence outcomes: ContM-only had the highest abstinence rates at posttreatment, and the MET+CBT+ContM combination had the highest rates at later follow-ups. The roles of contingency management and coping skills training in the treatment of marijuana dependence are discussed.
Behavioral therapies for treatment-seeking cannabis users: a meta-analysis of randomized controlled trials. [2022]Narrative reviews conclude that behavioral therapies (BTs) produce better outcomes than control conditions for cannabis use disorders (CUDs). However, the strength and consistency of this effect has not been directly empirically examined. The present meta-analysis combined multiple well-controlled studies to help clarify the overall impact of behavioral interventions in the treatment of CUDs. A comprehensive literature search produced 10 randomized controlled trials (RCTs; n = 2,027) that were included in the final analyses. Analyses indicated an effect of BTs (including contingency management, relapse prevention, and motivational interviewing, and combinations of these strategies with cognitive behavioral therapy) over control conditions (including waitlist [WL], psychological placebo, and treatment as usual) across pooled outcomes and time points (Hedges' g = 0.44). These results suggest that the average patient receiving a behavioral intervention fared better than 66% of those in the control conditions. BT also outperformed control conditions when examining primary outcomes alone (frequency and severity of use) and secondary outcomes alone (psychosocial functioning). Effect sizes were not moderated by inclusion of a diagnosis (RCTs including treatment-seeking cannabis users who were not assessed for abuse or dependence vs. RCTs including individuals diagnosed as dependent), dose (number of treatment sessions), treatment format (either group vs. individual treatment or in-person vs. non-in-person treatment), sample size, or publication year. Effect sizes were significantly larger for studies that included a WL control comparison versus those including active control comparisons, such that BT significantly outperformed WL controls but not active control comparisons.
A perfect platform: combining contingency management with medications for drug abuse. [2018]Contingency management (CM) procedures, which provide concrete reinforcers or rewards contingent on verification of discrete targeted behaviors, such as drug-free urines, have been demonstrated to be effective in a number of clinical trials. However, to date there have been only a few that have capitalized on the unique strengths and capabilities of CM as an ideal platform to improve response to or address weaknesses of many pharmacotherapies used in the treatment of drug abuse. In this review, we describe the multiple potential uses of CM as a platform for pharmacotherapy, including reducing illicit drug use in the context of agonist therapies; fostering medication compliance with antagonists, aversive agents and HIV medications; fostering a period of abstinence prior to initiation of agents used to treat comorbid psychiatric conditions or in the context of vaccines to foster adequate periods of abstinence while titer levels are building; and to enhance the effectiveness of anticraving agents through additive or synergistic effects. Although its multiple strengths render it an almost perfect platform, CM does have some weaknesses that have limited its use to date, including cost, the short-term nature of its effects, and need for training. Future treatment development of CM as a medication platform needs to counter these issues by focusing on CM applications with large potential benefit, developing simple or automated methods for CM delivery and placing greater emphasis on the process of transitioning away from formal CM treatment.
Measuring Within-Individual Cannabis Reduction in Clinical Trials: A Review of the Methodological Challenges. [2022]Cannabis abstinence traditionally is the primary outcome in cannabis use disorder (CUD) treatment trials. Due to the changing legality of cannabis, patient goals, and preliminary evidence that suggests individuals who reduce their cannabis use may show functional improvements, cannabis reduction is a desirable alternative outcome in CUD trials. We review challenges in measuring cannabis reduction and the evidence to support various definitions of reduction.
Treatment models for targeting tobacco use during treatment for cannabis use disorder: case series. [2021]Approximately 50% of individuals seeking treatment for cannabis use disorders (CUD) also smoke tobacco, and tobacco smoking is a predictor of poor outcomes for those in treatment for CUD. Quitting tobacco is associated with long-term abstinence from alcohol and illicit drugs, yet there are no established treatments for CUD that also target tobacco smoking. This report highlights issues related to cannabis and tobacco co-use and discusses potential treatment approaches targeting both substances. Data is shared from the first six participants enrolled in an intervention designed to simultaneously target tobacco use in individuals seeking treatment for CUD. The twelve-week program comprised computer-assisted delivery of Motivational Enhancement Therapy, Cognitive Behavioral Therapy, and Contingency Management, i.e., abstinence-based incentives for CUD. In addition, participants were encouraged to complete an optional tobacco intervention consisting of nicotine-replacement therapy and computer-assisted delivery of a behavioral treatment tailored for tobacco and cannabis users. All participants completed the cannabis intervention and at least a portion of the tobacco intervention: all completed at least one tobacco computer module (mean=2.5 modules) and 50% initiated nicotine replacement therapy. Five of six participants achieved abstinence from cannabis. The number of tobacco quit attempts was lower than expected, however all participants attempted to reduce tobacco use during treatment. Simultaneously targeting tobacco during treatment for CUD did not negatively impact cannabis outcomes. Participation in the tobacco intervention was high, but cessation outcomes were poor suggesting that alternative strategies might be needed to more effectively prompt quit attempts and enhance quit rates.
A preliminary trial: double-blind comparison of nefazodone, bupropion-SR, and placebo in the treatment of cannabis dependence. [2021]The present study investigated the efficacy of nefazodone and bupropion-sustained release for treating cannabis dependence. A double-blind, placebo-controlled, piggy back design was employed to assess if nefazodone and bupropion-sustained release increased the probability of abstinence from cannabis and reduced the severity of cannabis dependence and cannabis withdrawal symptoms during a 13-week outpatient treatment program. One-hundred and six participants (Mean = 32 years; females n = 25) were randomized to one of three medication conditions (nefazodone, bupropion-sustained release, or placebo) and participated in a weekly, individually based coping skills therapy program. Results indicated an increased probability of achieving abstinence over the course of treatment and a decrease in the severity of cannabis dependence and the withdrawal symptom of irritability. There were no significant effects demonstrated for nefazodone and bupropion-sustained release on cannabis use or cannabis withdrawal symptoms. The results indicate nefazodone and bupropion-sustained release may have limited efficacy in treating cannabis dependence.