N/A
Completed N=120
Financial Incentives, Randomization With Stepped Treatment Trial
Unhealthy Alcohol Use
Source: ClinicalTrials.gov NCT03089320 ↗
Enrolled (actual)
120
Serious AEs
7.5%
Results posted
Apr 2024
Primary outcomePrimary: Self-reported Abstinence From Alcohol — 9.44; 0.32 percentage of participants
Summary
The investigators plan to determine the effectiveness of contingency management (CM) plus stepped care for unhealthy alcohol use in HIV-positive patients.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Self-reported Abstinence From Alcohol |
9.44; 0.32 | — |
| SECONDARY Proportion of Participants of Participants With Phosphatidylethanol (PeTH) Documented Abstinence by the Alcohol Biomarker, Phosphatidylethanol (PEth) |
5.86; 0.36 | — |
| SECONDARY Change in Biological Markers as Measured by the VACS Index |
30.25; 35.57 | .05 |
Eligibility Criteria
Inclusion Criteria
- Be HIV-infected.
- Recent significant alcohol consumption as determined by a PEth greater than 20 ng/ml.
- Able to provide informed consent.
- Meet any of the following criteria for unhealthy alcohol use:
- At-risk Drinking - greater than 14 drinks per week or greater than 4 drinks per occasion in men and greater than 7 drinks per week or greater than 3 drinks per occasion in women and those over 65.161
- Medical condition impacted by alcohol as evidenced by one of the following: 1) detectable HIV viral load (>200 copies/ml),) tobacco use disorder and smoking more than 5 cigarettes per day, 3) detectable HCV virus, 4) liver fibrosis with a FIB-4 >1.45) Patient Health Questionnaire (PHQ-9, validated measure for depression) score greater than 9, or 6) current (at least 30 day supply in the past 60 days) prescription for a psychoactive medication that interacts with alcohol-including benzodiazepines, opioids, antipsychotics, antidepressants, sleeping medications and muscle relaxants.
- Alcohol Use Disorder - Meet DSM-5 criteria for alcohol use disorder, not in remission
Exclusion Criteria
No subject may:
- Be acutely suicidal, or with a psychiatric condition that affects his/her ability to provide informed consent or participate in counseling interventions (e.g. psychotic, dementia, delusional).
- Be currently enrolled in formal treatment for alcohol (excluding mutual-help, e.g. Alcoholics Anonymous)
- Have medical conditions that would preclude completing or be of harm during the course of the study.
- Be a pregnant or nursing woman or women who do not agree to use a reliable form of birth control.
- Have a current diagnosis of or be in remission for a gambling disorder given the gaming nature of CM.
Data sourced from ClinicalTrials.gov (NCT03089320). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.