Contingency Management for Cannabis Use in HIV

Recruiting at 2 trial locations

Overseen By Chukwuemeka N Okafor, PhD, MPH

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: The University of Texas Health Science Center at San Antonio

Must not be taking: Opioids

Disqualifiers: Major depression, Anxiety, Alcohol use disorder, others

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

Compensation: Varies

Number of Visits: 7

Duration: 4 weeks

45 Participants Needed

Trial Summary

What is the purpose of this trial?

The purpose of this study is to determine the feasibility and impact of 28-days of monitored abstinence from cannabis use on symptoms of depression and anxiety, pain, sleep, cannabis use withdrawal, HIV viral load and biomarkers of systemic inflammation among PLWH and who use cannabis regularly (weekly or more often). This will be a single arm pilot feasibility trial involving a contingency management program to induce cannabis abstinence. Specifically, the contingency management program will provide motivational (monetary) incentives to participants who achieve biochemically verified cannabis abstinence. Over the 28-days of this pilot feasibility trial, participants will attend seven study visits. During these visits, participants will complete survey questionnaires to assess sociodemographic, psychosocial, and behavioral factors. In addition, participants will provide blood and urine specimens for testing and quantitation of HIV viral load, biomarkers of systemic inflammation and for the detection of cannabis and other drugs of abuse.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. However, you must be willing to stop using cannabis for 28 days.

What data supports the effectiveness of the treatment Contingency Management for Cannabis Use in HIV?

Research shows that Contingency Management (CM) is effective in reducing cannabis use and achieving abstinence, especially in individuals with co-occurring mental health disorders. Additionally, CM has been successful in increasing abstinence rates in marijuana-dependent individuals when combined with other therapies. ^{1 2 3 4 5}

Is contingency management safe for humans?

Contingency management (CM) has been used safely in various studies for treating substance use disorders, including cannabis use disorder, often in combination with other therapies. Participants in these studies did not report significant safety concerns, suggesting that CM is generally safe for human use. ^{1 2 3 6 7}

How is the treatment Contingency Management for Cannabis Use in HIV different from other treatments?

Contingency Management is unique because it uses tangible rewards, like vouchers, to encourage cannabis abstinence, making it different from other treatments that may not offer direct incentives for behavior change. ^{2 3 8 9 10}

Research Team

Chukwuemeka N Okafor, PhD, MPH

Principal Investigator

The University of Texas Health Science Center at San Antonio

Eligibility Criteria

This trial is for people living with HIV who use cannabis at least weekly, can speak English, and are willing to try not using cannabis for 28 days while attending study visits. They must have a positive urine test for cannabis but cannot be seeking treatment for its use or have any major substance abuse disorders (except nicotine), psychiatric conditions, or other issues that could make the trial unsafe.

Inclusion Criteria

You are currently using cannabis and are not willing to stop using it during the study.

You have used cannabis at least once a week for the six months before agreeing to participate in the study.

You are willing to stop using cannabis for 28 days and attend eight study visits over six weeks.

Exclusion Criteria

I do not have a current alcohol or substance use disorder.

Having a medical, psychiatric, occupational, or other condition that, in the judgment of the study physician, would make participation difficult or unsafe.

Positive UTOX screen for opioids

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo a 28-day monitored abstinence from cannabis use with motivational incentives for verified abstinence

4 weeks

7 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Contingency Management - Cannabis

Trial Overview The study tests if giving money as motivation helps participants stop using cannabis for 28 days. It looks at how quitting affects their depression, anxiety, pain, sleep quality, withdrawal symptoms from stopping cannabis use, HIV viral load levels and inflammation markers in the body.

Participant Groups

Group I: Contingency Management - Cannabis Experimental Treatment 1 Intervention

Participants will be incentivized following biochemical verification (from urine samples) of cannabis abstinence.

Who Is Running the Clinical Trial?

The University of Texas Health Science Center at San Antonio

Lead Sponsor

Trials

486

Recruited

92,500+

Baylor University

Lead Sponsor

Trials

65

Recruited

67,600+

The University of Texas Health Sciences Center, Houston

Collaborator

Trials

1

Recruited

50+

National Institute on Drug Abuse (NIDA)

Collaborator

Trials

2,658

Recruited

3,409,000+

Findings from Research

A novel multi-target contingency management (CM) program was developed for HIV positive substance users, integrating various health and behavior targets to improve outcomes over a 6-month period.

The primary goal of the program is to achieve viral load suppression at 12 months, with participants able to earn up to $1160 through completing tasks related to health care visits, medication adherence, and drug use abatement, indicating a comprehensive approach to managing both health and substance use behaviors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Development of a Multi-Target Contingency Management Intervention for HIV Positive Substance Users. Stitzer, M., Calsyn, D., Matheson, T., et al.[2019]

In a study involving 240 marijuana-dependent participants, adding contingency management (ContM) to motivational enhancement therapy plus cognitive behavioral therapy (MET+CBT) significantly improved abstinence rates compared to other treatment conditions.

The ContM-only group achieved the highest abstinence rates immediately after treatment, while the combination of MET+CBT and ContM showed the best outcomes at follow-up, highlighting the effectiveness of reinforcement strategies in treating marijuana dependence.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Abstinence rates following behavioral treatments for marijuana dependence. Kadden, RM., Litt, MD., Kabela-Cormier, E., et al.[2022]

Contingency management (CM) has been shown to effectively reduce cannabis use and promote abstinence in individuals with comorbid cannabis use disorder and mental health disorders, particularly those with psychotic-spectrum or major depressive disorders.

The review included six studies, indicating a need for more extensive longitudinal research with larger sample sizes and diverse psychiatric populations to better understand the long-term effects of CM.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Contingency Management for Treatment of Cannabis Use Disorder in Co-Occurring Mental Health Disorders: A Systematic Review. Rodas, JD., Sorkhou, M., George, TP.[2023]

The study found that a contingency management procedure significantly reduced cocaine use in health-compromised patients, with a notable decrease in cocaine metabolite levels and an increase in cocaine-free samples, especially in the TB-exposed group (n=5).

Pregnant women (n=7) also showed improved compliance with prenatal visits during the treatment, indicating that this approach not only helps reduce drug use but also supports better health outcomes for both mothers and their babies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Behavioral treatment of cocaine-dependent pregnant women and TB-exposed patients. Elk, R., Schmitz, J., Spiga, R., et al.[2019]

A meta-analysis of 10 randomized controlled trials involving 2,027 participants found that behavioral therapies (BTs) significantly improve outcomes for cannabis use disorders compared to control conditions, with an effect size of 0.44, indicating that patients receiving BTs fared better than 66% of those in control groups.

Behavioral therapies were effective in reducing both the frequency and severity of cannabis use, as well as improving psychosocial functioning, with larger effect sizes observed in studies using waitlist controls compared to those with active control comparisons.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Behavioral therapies for treatment-seeking cannabis users: a meta-analysis of randomized controlled trials. Davis, ML., Powers, MB., Handelsman, P., et al.[2022]

A study involving 110 HIV-positive sexual minority men showed that a positive affect intervention, when combined with contingency management (CM), significantly increased positive feelings and mindfulness over three months.

Participants who received the positive affect intervention experienced reduced cravings for methamphetamine and reported lower stimulant use, suggesting that enhancing emotional well-being can improve treatment outcomes in substance use disorders.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Randomized controlled trial of a positive affect intervention for methamphetamine users. Carrico, AW., Gόmez, W., Jain, J., et al.[2023]

A combination of motivational enhancement therapy (MET), cognitive-behavioral therapy (CBT), and contingency management (CM) is effective for treating cannabis use disorders, and a computer-assisted version of this treatment shows promise in overcoming barriers to access.

In a 12-week study with 38 adults, both therapist-delivered and computer-delivered treatments resulted in similar attendance and cannabis use outcomes, indicating that computer-assisted therapy is a viable alternative that maintains treatment effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An initial trial of a computerized behavioral intervention for cannabis use disorder. Budney, AJ., Fearer, S., Walker, DD., et al.[2021]

The study is testing the effectiveness of a 5-session intervention called ARTEMIS, which aims to help HIV-positive men who use methamphetamine by enhancing their ability to manage emotions and find rewards outside of drug use, alongside a 12-week contingency management program.

The primary goal of the trial is to assess the impact of ARTEMIS on HIV viral load, with secondary outcomes including sustained viral suppression and psychological adjustment, highlighting its potential to improve both health and substance use outcomes in this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A community-engaged randomized controlled trial of an integrative intervention with HIV-positive, methamphetamine-using men who have sex with men. Carrico, AW., Jain, J., Discepola, MV., et al.[2019]

Contingency management (CM) is an effective treatment strategy that reinforces positive behaviors, such as drug abstinence and counseling attendance, and shows promise in improving HIV-related behaviors.

CM interventions, including voucher systems and cash incentives, can significantly reduce HIV risk behaviors and enhance adherence to HIV medications, making them versatile tools for both prevention and management in various settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Contingency management interventions for HIV-related behaviors. Haug, NA., Sorensen, JL.[2019]

The integrated cognitive behavioral and contingency management (CBT/CM) intervention was found to be acceptable and feasible for young people living with HIV, with 80% of the 17 participants (ages 18-24) completing the study.

Participants experienced significant reductions in alcohol use, withdrawal symptoms, and depressive symptoms, indicating that this tailored intervention may effectively improve substance use and mental health outcomes for this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Substance abuse treatment for HIV infected young people: an open pilot trial. Esposito-Smythers, C., Brown, LK., Wolff, J., et al.[2022]

References

1. United States pubmed.ncbi.nlm.nih.gov

Development of a Multi-Target Contingency Management Intervention for HIV Positive Substance Users. [2019]

2. England pubmed.ncbi.nlm.nih.gov

Abstinence rates following behavioral treatments for marijuana dependence. [2022]

3. Switzerland pubmed.ncbi.nlm.nih.gov

Contingency Management for Treatment of Cannabis Use Disorder in Co-Occurring Mental Health Disorders: A Systematic Review. [2023]

4. England pubmed.ncbi.nlm.nih.gov

Behavioral treatment of cocaine-dependent pregnant women and TB-exposed patients. [2019]

5. United States pubmed.ncbi.nlm.nih.gov

Behavioral therapies for treatment-seeking cannabis users: a meta-analysis of randomized controlled trials. [2022]

6. Ireland pubmed.ncbi.nlm.nih.gov

Randomized controlled trial of a positive affect intervention for methamphetamine users. [2023]

7. Ireland pubmed.ncbi.nlm.nih.gov

An initial trial of a computerized behavioral intervention for cannabis use disorder. [2021]

8. England pubmed.ncbi.nlm.nih.gov

A community-engaged randomized controlled trial of an integrative intervention with HIV-positive, methamphetamine-using men who have sex with men. [2019]

9. United States pubmed.ncbi.nlm.nih.gov

Contingency management interventions for HIV-related behaviors. [2019]

10. United States pubmed.ncbi.nlm.nih.gov

Substance abuse treatment for HIV infected young people: an open pilot trial. [2022]