Clinical trial NCT04866004: 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
Overall status: RECRUITING
Phase: NA
Conditions: Marijuana
HIV Infections
Lead sponsor: The University of Texas Health Science Center at San Antonio
Sponsor class: OTHER
Collaborators: name: The University of Texas Health Sciences Center, Houston
name: National Institute on Drug Abuse (NIDA)
First posted: 2021-04-29
Enrollment: 45
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

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.


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.

Primary outcomes:
measure: Sustained cannabis abstinence for 28-days
timeFrame: 28-days
Secondary outcomes:
Other outcomes:
Locations:
city: Houston
country: United States
facility: Center for Neurobehavioral Research on Addiction
state: Texas
city: San Antonio
country: United States
facility: University of Texas Health Science Center at San Antonio
state: Texas
Study officials:
affiliation: The University of Texas Health Science Center at San Antonio
name: Chukwuemeka N Okafor, PhD, MPH
role: PRINCIPAL_INVESTIGATOR
References: