Trial Summary
What is the purpose of this trial?Cognitive impairment is well established in people with psychosis and is associated with cannabis use. The current study will investigate the neurobiological basis of cognitive change associated with 28-days of cannabis abstinence in people with psychosis and non-psychiatric controls with cannabis use. Participants will be randomized to a cannabis abstinent group or a non-abstinent control group and will undergo magnetic resonance imaging at baseline and following 28-days of abstinence. This study will help characterize the neuropathophysiological processes underlying cognitive dysfunction associated with cannabis use and its recovery which may guide the development of novel interventions for problematic cannabis use.
Is the treatment in the trial 'Contingency Management for Psychosis' promising?Yes, contingency management is a promising treatment because it uses rewards to encourage people to stick with their mental health treatment, which can lead to better outcomes. Studies show that using rewards like vouchers or prizes helps people stay in treatment longer and achieve longer periods of improvement.127910
What safety data exists for Contingency Management in psychosis treatment?The provided research does not directly address safety data for Contingency Management in psychosis treatment. However, studies like the CIRCLE randomized clinical trial and the 'Money for Medication' study suggest that Contingency Management has been evaluated for its effectiveness and cost-effectiveness in improving treatment adherence and reducing substance use in psychosis. These studies imply a focus on clinical outcomes rather than explicit safety data, indicating a need for further research specifically addressing safety.456810
Do I have to stop taking my current medications for the trial?The trial does not specify if you need to stop taking your current medications. However, if you are in the psychosis patient arm, you must be on a stable dose of medication for at least two months. If you are a non-psychiatric control, you cannot be taking psychotropic medication.
What data supports the idea that Contingency Management for Psychosis is an effective treatment?The available research shows that Contingency Management (CM) can be effective in improving medication adherence in patients with psychotic disorders. A study titled 'Money for Medication' found that using financial incentives helped patients stick to their medication schedules better. This approach has also shown promise in reducing hospital admission days. While CM is widely used for substance use disorders, its application in psychosis treatment is still being explored, but initial results are encouraging.347910
Eligibility Criteria
This trial is for adults who use cannabis heavily and either have psychosis or no psychiatric conditions. Participants must speak English or French, have an IQ over 75, and be stable on medications if they have psychosis. They can't join if they use other psychoactive substances, are suicidal, pregnant, need hospitalization for medical issues, take psychotropic meds (except those with psychosis), or have MRI contraindications.Exclusion Criteria
I am currently taking medication for my mental health.
I have been hospitalized for a head injury or was unconscious for more than 5 minutes.
I have a medical condition that needs regular hospital visits.
Treatment Details
The study examines how stopping cannabis affects brain function in people with and without psychosis over 28 days. It involves random assignment to a group that quits using cannabis or a control group that continues as usual. Brain changes will be monitored using MRI scans before and after the abstinence period.
5Treatment groups
Experimental Treatment
Active Control
Group I: Psychosis patients with cannabis use (Abstinent)Experimental Treatment1 Intervention
Psychosis patients with cannabis use will receive contingency management to encourage cannabis abstinence for 28 days
Group II: Non-Psychiatric controls with cannabis use (Abstinent)Experimental Treatment1 Intervention
Non-Psychiatric controls with cannabis use will receive contingency management to encourage cannabis abstinence for 28 days
Group III: Psychosis patients with cannabis use (Non-abstinent)Active Control1 Intervention
Psychosis Patients with cannabis use who will continue to use cannabis as usual
Group IV: Non-Psychiatric controls with cannabis use (Non-abstinent)Active Control1 Intervention
Non-Psychiatric Controls with cannabis use will continue to use cannabis as usual
Group V: Non-Psychiatric Controls without cannabis useActive Control1 Intervention
Non-Psychiatric controls without cannabis use
Find a clinic near you
Research locations nearbySelect from list below to view details:
Douglas Mental Health University InstituteMontréal, Canada
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Who is running the clinical trial?
Douglas Mental Health University InstituteLead Sponsor
References
Contingency management of food misbehavior in a psychiatric patient with diabetes. [2019]A contingency management procedure was instituted with a hospitalized 52-year-old male psychiatric patient to alter behavior associated with an exacerbated diabetic condition. A ten-day baseline indicated consistently elevated urine sugar levels and that the patient frequently violated his prescribed low sugar diet by stealing, trading and hoarding high sugar foods. Beginning in baseline, the patient was instructed to measure his urine sugar levels and post the results on a chart next to his bed. During two of the intervention procedures used in the additive design, the patient could earn coupon booklets from the hospital commissary if his daily average urine sugar levels were less than a set criterion. Two such criteria were employed before the reinforcement contingencies were faded. By the end of the intervention, urine sugar levels were under control and follow-up measures six months post-treatment indicated durable treatment effects.
Vouchers versus prizes: contingency management treatment of substance abusers in community settings. [2016]Contingency management (CM) interventions usually use vouchers as reinforcers, but a new technique awards chances of winning prizes. This study compares these approaches. In community treatment centers, 142 cocaine- or heroin-dependent outpatients were randomly assigned to standard treatment (ST), ST with vouchers, or ST with prizes for 12 weeks. CM patients remained in treatment longer and achieved greater durations of objectively confirmed abstinence than did ST patients; CM conditions did not differ significantly. Although abstinence at 6- and 9-month follow-ups did not differ by group, the best predictor of abstinence was longest duration of abstinence achieved during treatment. Thus, prize and voucher CM systems are equally efficacious in promoting long durations of abstinence, which in turn are associated with benefits posttreatment.
Effectiveness of motivational incentives in stimulant abusing outpatients with different treatment histories. [2019]To determine if prize-based abstinence incentives will differentially affect substance abuse outcomes in patients with different treatment histories.
Money for medication: a randomized controlled study on the effectiveness of financial incentives to improve medication adherence in patients with psychotic disorders. [2018]Non-adherence with antipsychotic medication is a frequently occurring problem, particularly among patients with psychotic disorders. Prior research has generally shown encouraging results for interventions based on 'Contingency Management' (CM), in which desirable behaviour is encouraged by providing rewards contingent upon the behaviour. However, little is known about the application of CM on medication adherence in patients with psychotic disorders. An earlier pilot-study by our study group showed promising results in reducing admission days and increasing adherence. The current study is a randomized controlled trial concerning the effectiveness of a CM procedure called 'Money for Medication' (M4M), aimed at improving adherence with antipsychotic depot medication in psychotic disorder patients.
Paying for Early Interventions in Psychoses: A Three-Part Model. [2015]Widespread dissemination of early interventions for psychosis, such as the intervention offered in the RAISE study (Recovery After an Initial Schizophrenia Episode), requires a funding mechanism that is both compatible with approaches already used by payers and generates incentives for providers that promote the desired behaviors. The authors propose a funding model with three components: a prospective per-case payment made conditional on patient engagement in treatment, a per-service component to cover the costs of clinical services, and an outcome-based component conditional on achieving measurable outcome milestones. The authors describe the components and how such a payment mechanism might be implemented.
Contingency Management Abstinence Incentives: Cost and Implications for Treatment Tailoring. [2019]To examine prize-earning costs of contingency management (CM) incentives in relation to participants' pre-study enrollment drug use status (baseline (BL) positive vs. BL negative) and relate these to previously reported patterns of intervention effectiveness.
Examining implementation of contingency management in real-world settings. [2021]Very little is known about how reward programs are implemented in real-world substance use treatment settings and whether training in contingency management (CM), an empirically supported rewards-based intervention, impacts their design quality. Providers (N = 214) completed surveys assessing CM beliefs, training, and practices related to use of tangible rewards in treatment. For providers reporting they had not used rewards in treatment previously (54%, n = 116), we assessed beliefs about and interest in adopting a reward-based program. For those endorsing prior reward experience (46%, n = 98), we assessed the features and delivery of rewards and the relation of reward-based intervention training to 4 parameters related to CM efficacy: reinforcement magnitude, immediacy, frequency, and escalation. Among providers without reward experience, endorsement of supportive statements about CM predicted interest in adopting a rewards-based program. Providers with reward experience most often targeted treatment attendance and engaged in behaviors likely to decrease the effectiveness of the intervention, including use of low magnitudes (≤ $25/client), delayed reinforcement, failure to escalate reward values, and offering reward opportunities less than weekly. Providers with longer durations of training were more likely to engage in behaviors consistent with effective CM, including larger magnitude rewards and immediate delivery of rewards. Results indicate that real-world treatment clinics are using reward-based programs but not in ways consistent with research protocols. Longer training exposure is associated with greater adherence to some aspects of CM protocol design. Other evidence-based design features are not being implemented as recommended, even with training. (PsycINFO Database Record (c) 2020 APA, all rights reserved).
Clinical and cost-effectiveness of contingency management for cannabis use in early psychosis: the CIRCLE randomised clinical trial. [2021]Cannabis is the most commonly used illicit substance amongst people with psychosis. Continued cannabis use following the onset of psychosis is associated with poorer functional and clinical outcomes. However, finding effective ways of intervening has been very challenging. We examined the clinical and cost-effectiveness of adjunctive contingency management (CM), which involves incentives for abstinence from cannabis use, in people with a recent diagnosis of psychosis.
A preliminary investigation of schedule parameters on cocaine abstinence in contingency management. [2023]Contingency management (CM) interventions are the most effective psychosocial interventions for substance use disorders. However, further investigation is needed to create the most robust intervention possible. This study investigated the effects of 1) reinforcer magnitude; and 2) fixed and escalating and resetting incentives on cocaine abstinence in an outpatient trial. In this analysis, 34 treatment-seeking individuals with Cocaine Use Disorder received either high or low value incentives for providing a benzoylecgonine-negative urine sample or were in a control condition and received incentives for providing a urine sample regardless of the results. Participants received either escalating and resetting incentives, wherein the value of each incentive increased with consecutive negative samples and reset to the initial level upon a positive sample (Experiment 1), or fixed incentives, wherein they received the same value incentive for each negative urine sample they provided (Experiment 2). Large incentives produced more abstinence, although escalating and resetting reinforcer values did not have a differential effect. Large, fixed incentives promoted abstinence faster than other reinforcers, whereas smaller incentives resulted in poor abstinence and took many visits to achieve initial abstinence. Future research comparing different schedules on cocaine abstinence in a randomized control trial with a larger sample size is required.
Do financial incentives increase mental health treatment engagement? A meta-analysis. [2023]Engagement in mental health treatment is low, which can lead to poor outcomes. We evaluated the efficacy of offering patients financial incentives to increase their mental health treatment engagement, also referred to as contingency management.