NCT04866004

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
25

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Aug 2021

Longer than P75 for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 27, 2021

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 29, 2021

Completed
3 months until next milestone

Study Start

First participant enrolled

August 1, 2021

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2025

Completed
Last Updated

September 4, 2025

Status Verified

August 1, 2025

Enrollment Period

4 years

First QC Date

April 27, 2021

Last Update Submit

August 27, 2025

Conditions

MarijuanaHIV Infections

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (1)

Contingency Management - Cannabis

EXPERIMENTAL

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

Behavioral: Contingency Management - Cannabis

Interventions

Contingency Management - CannabisBEHAVIORAL

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.

Contingency Management - Cannabis

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Center for Neurobehavioral Research on Addiction

Houston, Texas, 77054, United States

Location

University of Texas Health Science Center at San Antonio

San Antonio, Texas, 78229, United States

Location

MeSH Terms

Conditions

Marijuana AbuseHIV Infections

Condition Hierarchy (Ancestors)

Substance-Related DisordersChemically-Induced DisordersMental DisordersBlood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System Diseases

Study Officials

  • Chukwuemeka N Okafor, PhD, MPH

    The University of Texas Health Science Center at San Antonio

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

April 27, 2021

First Posted

April 29, 2021

Study Start

August 1, 2021

Primary Completion

July 31, 2025

Study Completion

July 31, 2025

Last Updated

September 4, 2025

Record last verified: 2025-08

Data Sharing

IPD Sharing
Will not share

Locations

US(2)