Contingency Management for Cannabis Use for Persons With HIV

HIV Infections Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04866004
• Other study ID #: HSC-MS-20-0886
• Secondary ID: K01DA047912HSC20
• Status: Recruiting
• Phase: N/A
• Start date: August 1, 2021
• Est. completion date: June 1, 2025

Study information

• Verified date: March 2024
• Source: The University of Texas Health Science Center at San Antonio
• Contact: Chukwuemeka N Okafor, PhD, MPH
• Phone: 857-225-3923
• Email: okaforcn[@]uthscsa.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 45
• Est. completion date: June 1, 2025
• Est. primary completion date: December 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• HIV Infections
• Marijuana

Intervention

Behavioral:
• Contingency Management - Cannabis
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.

Locations

Country	Name	City	State
United States	Center for Neurobehavioral Research on Addiction	Houston	Texas
United States	University of Texas Health Science Center at San Antonio	San Antonio	Texas

Sponsors (3)

Lead Sponsor	Collaborator
The University of Texas Health Science Center at San Antonio	National Institute on Drug Abuse (NIDA), The University of Texas Health Sciences Center, Houston

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Sustained cannabis abstinence for 28-days	Cannabis abstinence will be defined as sustained reduction in quantitative levels of 11-Nor-9-carboxy-??-tetrahydrocannabinol (THCCOOH) for 28-days	28-days