Contingency Management for Cannabis Use for Persons With HIV

Study Overview
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Brief Summary
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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.

Official Title
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Feasibility and Impact of 28-days of Monitored Abstinence From Cannabis Use on Symptoms of Distress, Inflammation, and HIV Viral Load

Conditions
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Marijuana, HIV Infections

Intervention / Treatment
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* Behavioral: Contingency Management - Cannabis


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: HIV-positive (confirmed via HIV medication or relevant HIV labs in subject's name) Self-report of cannabis use at least once per week in the 6-month period prior to consent Provide a positive urine toxicology (UTOX) screen for cannabis Not seeking treatment for cannabis use Willing to stop using cannabis for 28 days and attend eight study visits over six weeks. Ability and willingness to provide inform consent English fluency Exclusion Criteria: Currently receiving treatment for cannabis or other drug use disorder Diagnosed or receiving treatment for a current major depressive or anxiety disorder Diagnosed with any current alcohol or substance use disorder (excluding nicotine) using the Structured Clinical Interview for Clinical Disorders (SCID) Interview (22) Positive UTOX screen for opioids Having a medical, psychiatric, occupational, or other condition that, in the judgment of the study physician, would make participation difficult or unsafe.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Contingency Management - Cannabis<br>Participants will be incentivized following biochemical verification (from urine samples) of cannabis abstinence. | Behavioral: Contingency Management - Cannabis<br>* Participants in the contingency management program will be provided financial incentives for 28-days of cannabis abstinence. At every visit, participants will provide urine samples for the biochemical verification of cannabis abstinence). Participants with evidence of cannabis abstinence will be provided a financial incentive that increases across subsequent study visits.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sustained cannabis abstinence for 28-days | Cannabis abstinence will be defined as sustained reduction in quantitative levels of 11-Nor-9-carboxy-Δ⁹-tetrahydrocannabinol (THCCOOH) for 28-days | 28-days |