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NCT04791969 · ClinicalTrials.gov registry record · Phase 2
Intermittent Oral Naltrexone Enhanced With an Ecological Momentary Intervention for Methamphetamine-using MSM
A Phase 2 study of Methamphetamine Use Disorder, sponsored by Glenn-Milo Santos.
- Completed
- Registry status
- Phase 2
- Development phase
- 60
- Enrollment target
- 1
- Study location
NCT04791969 is a Phase 2 study of Methamphetamine Use Disorder that has completed, run by Glenn-Milo Santos. The registered enrollment target is 60 participants, above the 50-participant average among 12 other Methamphetamine Use Disorder trials with a reported enrollment target (20% higher). The trial reports 1 study location across 1 state.
The verdict
NCT04791969, a Phase 2 study of Methamphetamine Use Disorder, has completed, sponsored by Glenn-Milo Santos.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 60 participants
- Enrollment target
- 1
- Study location
Study Summary
This is a double-blind, placebo-controlled phase 2b trial in which 54 MSM who use meth will be randomly assigned (2:1) to receive 12 weeks of as-needed intermittent oral naltrexone 50 mg enhanced with an EMA-informed EMI platform, or receive as-needed placebo with EMA-informed EMI. The 12-week treatment period is consistent with other pharmacotherapy trials for substance use disorders. The proposed sample size is also consistent with other phase 2b trials for substance use treatment. Upon enrollment, participants will complete daily EMA assessments and weekly visits for behavioral surveys and urine testing for meth metabolites, study drug dispensing and computer-based counseling for substance use. Safety laboratory assessments and vital signs will be completed monthly. Efficacy (Specific Aims 1-3) will be assessed upon trial completion as measured by proportion meth-positive urine samples; PrEP and ART adherence by drug levels and viral load testing; and sexual risk behavior data accounting for PrEP use and viral suppression.
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Naltrexone Hydrochloride
- BEHAVIORAL Ecological Momentary Intervention
Study Locations (1)
California
- San Francisco Department of Public Health - San Francisco
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 60 participants |
| Start Date | 2021-12-14 |
| Est. Completion | 2024-07-01 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04791969
The ClinicalTrials.gov registry entry for NCT04791969 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 60 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 50-participant average among 12 other Methamphetamine Use Disorder trials with a reported enrollment target (20% higher). The listed sponsor is Glenn-Milo Santos, which has 3 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Methamphetamine Use Disorder appearing as the primary indexed condition, and to 3 interventions - of which Placebo is the first listed.
NCT04791969 reports 1 study location spanning 1 distinct geographic area - top geographies include California.
Frequently Asked Questions
What is clinical trial NCT04791969 about?
NCT04791969 is a clinical study titled "Intermittent Oral Naltrexone Enhanced With an Ecological Momentary Intervention for Methamphetamine-using MSM". This is a double-blind, placebo-controlled phase 2b trial in which 54 MSM who use meth will be randomly assigned (2:1) to receive 12 weeks of as-needed intermittent oral naltrexone 50 mg enhanced with an EMA-informed EMI platform, or receive as-needed placebo with EMA-informed EMI. The 12-week treat...
What is the current status of trial NCT04791969?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 60 participants. The study started on 2021-12-14. Estimated completion is 2024-07-01.
What conditions does trial NCT04791969 study?
This clinical trial studies the following conditions: Methamphetamine Use Disorder.
What interventions are being tested in trial NCT04791969?
The interventions under investigation include: Placebo (DRUG), Naltrexone Hydrochloride (DRUG), Ecological Momentary Intervention (BEHAVIORAL).
Who is sponsoring clinical trial NCT04791969?
This trial is sponsored by Glenn-Milo Santos, which has 3 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04791969 being conducted?
This trial has 1 study location across California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Related
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