Contingency Management for Psychosis

Recruiting at 1 trial location

Overseen By Charlene Osei-Afrifa

Age: Any Age

Sex: Any

Trial Phase: Academic

Sponsor: Douglas Mental Health University Institute

Must not be taking: Psychotropic medication

Disqualifiers: SUD, Suicidal ideation, Head injury, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 10

134 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how stopping cannabis use affects thinking skills in individuals with psychosis and those without psychiatric conditions. It aims to understand cannabis's impact on the brain and whether taking a break can improve cognitive functions. Participants will be divided into groups, with some continuing cannabis use and others encouraged to stop for 28 days. The study employs Contingency Management (also known as Motivational Incentives or the Prize Method), a behavioral therapy approach, to encourage participants to cease cannabis use. Ideal candidates include those with psychosis or without psychiatric conditions who have used cannabis heavily (weekly use for at least six months). This study may lead to new treatments for individuals struggling with cannabis-related issues. As an unphased trial, it offers participants the chance to contribute to groundbreaking research that could enhance understanding and treatment of cannabis-related cognitive issues.

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 psychosis patients be on a stable dose of their medication for at least two months. Non-psychiatric controls cannot be taking psychotropic medication.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research shows that contingency management, a treatment using rewards to encourage positive behaviors, is generally safe. It has been tested in individuals who use cannabis and those with mental health issues like psychosis. Studies have not identified any major safety concerns with this approach.

For example, one study found that contingency management helps reduce cannabis use without causing major side effects. Another review supports its effectiveness and safety for treating cannabis use disorder. Although specific safety data for people with psychosis isn't detailed, past uses in similar situations have not raised any alarms.

Therefore, participants in a trial can feel reassured that this method has been well-tolerated in the past. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the trial of contingency management for psychosis with cannabis use because it explores a behavioral approach rather than a medication-based treatment. Unlike traditional treatments for psychosis that often involve antipsychotic medications, this method uses positive reinforcement to encourage cannabis abstinence. This approach is particularly intriguing because it targets cannabis use, which can exacerbate psychotic symptoms. By focusing on behavior modification through rewards, researchers hope to uncover a non-pharmacological method to enhance the management of psychosis, offering a potentially effective and less invasive option for patients.

What evidence suggests that this trial's treatments could be effective for cognitive impairment in psychosis?

Research has shown that contingency management (CM) can help people reduce or stop using cannabis. CM involves offering rewards, such as money or vouchers, to encourage quitting. In this trial, some participants, specifically psychosis patients with cannabis use, will receive CM to promote abstinence for 28 days. This method has succeeded with individuals who have psychotic disorders or major depression. However, some studies found CM less effective for those with early psychosis. For individuals without psychiatric conditions, CM also helps reduce cannabis use by providing incentives to remain abstinent. Overall, CM is a promising method for addressing cannabis use, though results can vary depending on the group involved. ^{2 6 7 8 9}

Who Is on the Research Team?

Rachel Rabin, Ph. D.

Principal Investigator

Douglas Mental Health University Institute

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

Clinically stable (as measured by the PANSS-6, total score <30) (psychosis patient arm only)

I have been on a stable dose of my psychosis medication for at least two months.

Have a Full-Scale IQ ≥ 75

Exclusion Criteria

Positive urine screen for psychoactive substances other than cannabis, nicotine, or caffeine

Being pregnant

You cannot have an MRI scan due to certain medical reasons.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline Assessment

Participants undergo structural and functional MRI while completing a memory task

1 day

1 visit (in-person)

Treatment/Intervention

Participants are randomized to either a cannabis abstinent group or a non-abstinent control group for 28 days

4 weeks

8 visits (in-person) for urine sample collection

Follow-up

Participants undergo follow-up MRI to assess changes in brain activity and morphology after 28 days

1 day

1 visit (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Contingency Management

Trial Overview 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.

How Is the Trial Designed?

Group I: Psychosis patients with cannabis use (Abstinent) Experimental Treatment 1 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 Treatment 1 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 Control 1 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 Control 1 Intervention

Non-Psychiatric Controls with cannabis use will continue to use cannabis as usual

Group V: Non-Psychiatric Controls without cannabis use Active Control 1 Intervention

Non-Psychiatric controls without cannabis use

Who Is Running the Clinical Trial?

Douglas Mental Health University Institute

Lead Sponsor

Trials

31

Recruited

2,800+

Published Research Related to This Trial

In a study involving 551 participants with recent psychosis, the use of contingency management (CM) with incentives for cannabis abstinence did not significantly improve the time to acute psychiatric care compared to a control group receiving psychoeducation only.

Although the CM group showed a slightly lower median time to psychiatric admission (196 days) compared to the control group (245 days), the difference was not statistically significant, indicating that CM may not be an effective intervention for this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical and cost-effectiveness of contingency management for cannabis use in early psychosis: the CIRCLE randomised clinical trial. Sheridan Rains, L., Marston, L., Hinton, M., et al.[2021]

In a study involving 34 individuals with Cocaine Use Disorder, larger fixed incentives for providing negative urine samples led to faster and more effective abstinence compared to smaller incentives.

The type of incentive structure (escalating and resetting vs. fixed) did not significantly impact the overall effectiveness, suggesting that the magnitude of the incentive is more crucial for promoting abstinence.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A preliminary investigation of schedule parameters on cocaine abstinence in contingency management. Regnier, SD., Strickland, JC., Stoops, WW.[2023]

In a study of 255 substance users undergoing outpatient treatment, participants who were drug-free at the start (baseline negative) earned significantly more in contingency management (CM) incentives compared to those who were using drugs (baseline positive), with median prizes of $237 versus $44, respectively.

The findings suggest that tailoring CM interventions based on a participant's drug use status at treatment entry could enhance the effectiveness of abstinence-focused programs, as the majority of incentive expenditures were directed towards those who were already abstinent.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Contingency Management Abstinence Incentives: Cost and Implications for Treatment Tailoring. Cunningham, C., Stitzer, M., Campbell, AN., et al.[2019]

A survey of 214 substance use treatment providers revealed that while many clinics are using reward programs, they often do not follow effective practices recommended by research, such as providing higher reward amounts or immediate reinforcement.

Providers with more extensive training in contingency management (CM) were more likely to implement effective strategies, suggesting that better training could improve the quality of reward-based interventions in real-world settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Examining implementation of contingency management in real-world settings. Rash, CJ., Alessi, SM., Zajac, K.[2021]

In a study involving 142 outpatients with cocaine or heroin dependence, both voucher and prize-based contingency management (CM) interventions led to longer treatment retention and greater durations of confirmed abstinence compared to standard treatment.

While there were no significant differences in abstinence rates at 6- and 9-month follow-ups, the duration of abstinence achieved during treatment was the strongest predictor of continued abstinence after treatment ended.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Vouchers versus prizes: contingency management treatment of substance abusers in community settings. Petry, NM., Alessi, SM., Marx, J., et al.[2016]

A contingency management approach successfully helped a 52-year-old male psychiatric patient control his elevated urine sugar levels by incentivizing him to adhere to a low sugar diet, as evidenced by a ten-day baseline of poor dietary compliance.

Six months after the intervention, the patient maintained improved urine sugar levels, demonstrating the long-term effectiveness of the behavioral modification strategy employed.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Contingency management of food misbehavior in a psychiatric patient with diabetes. Duvinsky, JD., Jacobs, HE., Foy, DW.[2019]

Offering financial incentives significantly boosts engagement in mental health treatment, particularly for substance use disorders, with medium to large effect sizes for treatment attendance (Hedges' g = 0.49) and medication adherence (Hedges' g = 0.95).

The study highlights the need for further research on the effectiveness of financial incentives for a broader range of mental health disorders and emphasizes the importance of addressing ethical and systemic barriers to implementing these strategies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Do financial incentives increase mental health treatment engagement? A meta-analysis. Khazanov, GK., Morris, PE., Beed, A., et al.[2023]

Prize-based abstinence incentives combined with standard treatment did not show significant differences in effectiveness for patients with varying treatment histories, indicating that the incentives may be equally beneficial regardless of prior treatment experience.

The study involved treatment-seeking outpatients and assessed outcomes like the longest period of abstinence and negative urine drug screens, suggesting that these incentives can be a consistent motivational tool across diverse patient backgrounds.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of motivational incentives in stimulant abusing outpatients with different treatment histories. Killeen, T., Carter, R., Copersino, M., et al.[2019]

The proposed funding model for early interventions in psychosis, like the RAISE study, includes a per-case payment that encourages patient engagement, which is crucial for effective treatment.

This model also incorporates a per-service payment for clinical costs and an outcome-based payment that rewards providers for achieving specific treatment milestones, promoting better care for patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Paying for Early Interventions in Psychoses: A Three-Part Model. Frank, RG., Glied, SA., McGuire, TG.[2015]

The study involves 168 outpatients with psychotic disorders, randomly assigned to receive financial rewards for medication adherence or standard treatment, aiming to improve acceptance of antipsychotic depot medication over a 12-month period.

The primary goal is to evaluate the effectiveness of the 'Money for Medication' (M4M) intervention in increasing the percentage of accepted medication doses, while also assessing its impact on psychosocial functioning and overall patient wellbeing.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Money for medication: a randomized controlled study on the effectiveness of financial incentives to improve medication adherence in patients with psychotic disorders. Noordraven, EL., Audier, CH., Staring, AB., et al.[2018]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9855987/

Contingency Management for Treatment of Cannabis Use ... We found CM to be efficacious in producing cannabis use reductions and abstinence amongst individuals with a psychotic-spectrum or major depressive disorder.

2. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0376871624000176

Contingency management is associated with positive ... This study evaluated how short-duration contingency management (CM) impacts cannabis use attitudes and behavior after abstinence incentives are discontinued.

3. karger.com karger.com/ear/article/30/5/321/914353/Contingency-Management-for-Cannabis-Use-Disorder

Contingency Management for Cannabis Use Disorder ... Adding voucher-based incentives to coping skills and motivational enhancement improves outcomes during treatment for marijuana dependence.

4. jsatjournal.com jsatjournal.com/article/S0740-5472(15)00138-5/abstract

Effectiveness of Motivational Incentives for Adolescent ... Contingencies condition decreased marijuana use in adolescents at 8week follow up. •. Coping skills and treatment utilization increased in the contingency ...

5. link.springer.com link.springer.com/article/10.1007/s00406-024-01829-5

Effectiveness of cannabis use and cannabis use disorder ... Contingency Management (CM) uses money or vouchers as incentives (reinforcers) to increase treatment compliance and cannabis use goals. CM ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10923125/

Contingency Management is Associated with Positive ... This study evaluated how short-duration contingency management (CM) impacts cannabis use attitudes and behavior after abstinence incentives are discontinued.

7. library.samhsa.gov library.samhsa.gov/sites/default/files/contingency-management-advisory-pep24-06-001.pdf

contingency-management-advisory-pep24-06-001.pdf Contingency management (CM) is a proven health care intervention with demonstrated effectiveness in treating a variety of substance use disorders (SUDs) ...

8. clinicaltrials.gov clinicaltrials.gov/ct2/show/NCT04866004

Contingency Management for Cannabis Use for Persons ... Specifically, the contingency management program will provide motivational (monetary) incentives to participants who achieve biochemically verified cannabis ...

9. mdpi.com mdpi.com/2076-3425/13/1/36

Contingency Management for Treatment of Cannabis Use ... We found CM to be efficacious in producing cannabis use reductions and abstinence amongst individuals with a psychotic-spectrum or major depressive disorder.