Feasibility and Impact of 28-days of Monitored Abstinence From Cannabis Use on Symptoms of Distress, Inflammation, and HIV Viral Load
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 25
- Locations
- 4
- Primary Endpoint
- Sustained cannabis abstinence for 28-days
Study Overview
Brief Summary
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Other
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Outcomes
Primary Outcomes
Sustained cannabis abstinence for 28-days
Time Frame: 28-days
Cannabis abstinence will be defined as sustained reduction in quantitative levels of 11-Nor-9-carboxy-Δ⁹-tetrahydrocannabinol (THCCOOH) for 28-days
Secondary Outcomes
No secondary outcomes reported
Investigators
Chukwuemeka Okafor
Assistant Professor
The University of Texas Health Science Center at San Antonio