Contingency Management for Cannabis Use for Persons With HIV

Sponsor
Baylor University (Other)
Overall Status
Recruiting
CT.gov ID
NCT04866004
Collaborator
The University of Texas Health Sciences Center, Houston (Other)
45
2
1
23
22.5
1

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Contingency Management - Cannabis
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
45 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Other
Official Title:
Feasibility and Impact of 28-days of Monitored Abstinence From Cannabis Use on Symptoms of Distress, Inflammation, and HIV Viral Load
Actual Study Start Date :
Aug 1, 2021
Anticipated Primary Completion Date :
Jul 1, 2022
Anticipated Study Completion Date :
Jul 1, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: Contingency Management - Cannabis

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

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.

Outcome Measures

Primary Outcome Measures

  1. Sustained cannabis abstinence for 28-days [28-days]

    Cannabis abstinence will be defined as sustained reduction in quantitative levels of 11-Nor-9-carboxy-Δ⁹-tetrahydrocannabinol (THCCOOH) for 28-days

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Center for Neurobehavioral Research on Addiction Houston Texas United States 77054
2 Baylor University Waco Texas United States 76798

Sponsors and Collaborators

  • Baylor University
  • The University of Texas Health Sciences Center, Houston

Investigators

  • Principal Investigator: Chukwuemeka N Okafor, PhD, MPH, Baylor University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Emeka Okafor, Assistant Professor, Baylor University
ClinicalTrials.gov Identifier:
NCT04866004
Other Study ID Numbers:
  • HSC-MS-20-0886
First Posted:
Apr 29, 2021
Last Update Posted:
Mar 2, 2022
Last Verified:
Feb 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Mar 2, 2022