MarijuanaNCT04866004
Contingency Management for Cannabis Use for Persons With HIV
A study testing Contingency Management - Cannabis in people with Marijuana and HIV Infections, run by The University of Texas Health Science Center at San Antonio at 2 sites in United States.
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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Marijuana, HIV Infections
- What is being tested?
- Contingency Management - Cannabis
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 2 sitesUnited States
- Study dates
- 1 Aug 2021to 31 Jul 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Center for Neurobehavioral Research on Addiction
Houston, Texas, 77054
University of Texas Health Science Center at San Antonio
San Antonio, Texas, 78229
About this study
Official title: Feasibility and Impact of 28-days of Monitored Abstinence From Cannabis Use on Symptoms of Distress, Inflammation, and HIV Viral Load
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.
- Conditions
- Marijuana, HIV Infections
- Being tested
- Contingency Management - Cannabis
- Medical subject headings
- Marijuana Abuse, HIV Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Contingency Management - CannabisBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Contingency Management - Cannabis | Experimental | Participants will be incentivized following biochemical verification (from urine samples) of cannabis abstinence. Receives: Behavioral: Contingency Management - Cannabis |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 28-days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2021
- Study start1 Aug 2021
- Primary completion31 Jul 2025
- Study completion31 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MarijuanaStudies of the same condition, open and under way.
- More trials run by The University of Texas Health Science Center at San AntonioThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- The University of Texas Health Science Center, Houston, National Institute on Drug Abuse (NIDA)
- Responsible party
- Principal investigator, Chukwuemeka Okafor, The University of Texas Health Science Center at San Antonio
- Investigators
- Chukwuemeka N Okafor, PhD, MPH, Principal investigator, The University of Texas Health Science Center at San Antonio
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04866004
- Sponsor's protocol ID
- HSC-MS-20-0886
- Other IDs
- K01DA047912, HSC20220688H
- Status last verified
- Aug 2025
- First submitted
- 27 Apr 2021
- Last updated
- 4 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility and Impact of 28-days of Monitored Abstinence From Cannabis Use on Symptoms of Distress, Inflammation, and HIV Viral Load
- ClinicalTrials.gov ID
- NCT04866004
- Acronym / sponsor ID
- HSC-MS-20-0886
- Conditions
- Marijuana, HIV Infections
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- The University of Texas Health Science Center at San AntonioUniversity, hospital or other
- Collaborators
- The University of Texas Health Science Center, Houston, National Institute on Drug Abuse (NIDA)
- Study start
- 1 Aug 2021 (actual)
- Primary completion
- 31 Jul 2025 (actual)
- Study completion
- 31 Jul 2025 (actual)
- First posted
- 29 Apr 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Contingency Management - Cannabis | Experimental | Behavioral: Contingency Management - CannabisParticipants will be incentivized following biochemical verification (from urine samples) of cannabis abstinence. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Contingency Management - CannabisParticipants 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. | Behavioural | Contingency Management - Cannabis |
Primary outcome
Sustained cannabis abstinence for 28-days
Time frame: 28-days
Cannabis abstinence will be defined as sustained reduction in quantitative levels of 11-Nor-9-carboxy-Δ⁹-tetrahydrocannabinol (THCCOOH) for 28-days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Sep 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Chukwuemeka N Okafor, PhD, MPH principal investigator
The University of Texas Health Science Center at San Antonio
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Contingency Management - Cannabis in people with Marijuana and HIV Infections, run by The University of Texas Health Science Center at San Antonio at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sustained cannabis abstinence for 28-days (time frame: 28-days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Sep 2025.