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Contingency Management for Cannabis Use for Persons With HIV

Primary Purpose

Marijuana, HIV Infections

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Contingency Management - Cannabis
Sponsored by
The University of Texas Health Science Center at San Antonio
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Marijuana

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Center for Neurobehavioral Research on AddictionRecruiting
  • University of Texas Health Science Center at San Antonio

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Contingency Management - Cannabis

Arm Description

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
April 27, 2021
Last Updated
July 6, 2023
Sponsor
The University of Texas Health Science Center at San Antonio
Collaborators
The University of Texas Health Sciences Center, Houston, National Institute on Drug Abuse (NIDA)
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1. Study Identification

Unique Protocol Identification Number
NCT04866004
Brief Title
Contingency Management for Cannabis Use for Persons With HIV
Official Title
Feasibility and Impact of 28-days of Monitored Abstinence From Cannabis Use on Symptoms of Distress, Inflammation, and HIV Viral Load
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 1, 2021 (Actual)
Primary Completion Date
February 1, 2024 (Anticipated)
Study Completion Date
March 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The University of Texas Health Science Center at San Antonio
Collaborators
The University of Texas Health Sciences Center, Houston, National Institute on Drug Abuse (NIDA)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Marijuana, HIV Infections

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
45 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Contingency Management - Cannabis
Arm Type
Experimental
Arm Description
Participants will be incentivized following biochemical verification (from urine samples) of cannabis abstinence.
Intervention Type
Behavioral
Intervention Name(s)
Contingency Management - Cannabis
Intervention Description
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.
Primary Outcome Measure Information:
Title
Sustained cannabis abstinence for 28-days
Description
Cannabis abstinence will be defined as sustained reduction in quantitative levels of 11-Nor-9-carboxy-Δ⁹-tetrahydrocannabinol (THCCOOH) for 28-days
Time Frame
28-days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Chukwuemeka N Okafor, PhD, MPH
Phone
857-225-3923
Email
okaforc1@uthscsa.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Chukwuemeka N Okafor, PhD, MPH
Organizational Affiliation
The University of Texas Health Science Center at San Antonio
Official's Role
Principal Investigator
Facility Information:
Facility Name
Center for Neurobehavioral Research on Addiction
City
Houston
State/Province
Texas
ZIP/Postal Code
77054
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rolanda Johnson
Phone
713-486-2823
Email
rolanda.johnson@uth.tmc.edu
Facility Name
University of Texas Health Science Center at San Antonio
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Chukwuemeka N Okafor, PhD, MPH

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Contingency Management for Cannabis Use for Persons With HIV

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