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NCT03884946

The Getting Off App for Methamphetamine-Using Gay and Bisexual Men

Completed NA Results posted Last updated 29 January 2026
What this trial tests

NA trial testing Getting Off App in Methamphetamine Abuse in 226 participants. Completed in 26 April 2024.

Timeline
30 January 2019
Primary endpoint
26 April 2024
26 April 2024

Quick facts

Lead sponsorFriends Research Institute, Inc.
PhaseNA
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingnone
Primary purposetreatment
Enrollment226
Start date30 January 2019
Primary completion26 April 2024
Estimated completion26 April 2024
Sites1 location across United States

Drugs / interventions tested

Conditions studied

Sponsor

Friends Research Institute, Inc.

Who can join

Adults 18 to 65, male only, with Methamphetamine Abuse or HIV/AIDS. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Methamphetamine Use Primary · from baseline to 9-months post randomization

Days of participant self-reported methamphetamine use in the past 30 days.

Baseline
GroupValue95% CI
Immediate Delivery (ID)13.6± 11.3
Delayed Delivery (DD)15.3± 11.2
1 month
GroupValue95% CI
Immediate Delivery (ID)10.9± 10.3
Delayed Delivery (DD)14.5± 11.8
2 months
GroupValue95% CI
Delayed Delivery (DD)14.4± 10.7
3 months
GroupValue95% CI
Immediate Delivery (ID)9.4± 10.0
Delayed Delivery (DD)13.4± 11.6
6 months
GroupValue95% CI
Immediate Delivery (ID)10.2± 10.7
Delayed Delivery (DD)13.2± 11.6
9 months
GroupValue95% CI
Immediate Delivery (ID)8.8± 9.6
Delayed Delivery (DD)11.7± 11.5
Methamphetamine Injection Primary · From baseline to 9-months post randomization

Days participants self-reported methamphetamine injection use in past 30 days

Baseline
GroupValue95% CI
Immediate Delivery (ID)2.2± 5.5
Delayed Delivery (DD)2.3± 5.9
1 month
GroupValue95% CI
Immediate Delivery (ID)1.2± 4.4
Delayed Delivery (DD)2.3± 5.8
2 months
GroupValue95% CI
Delayed Delivery (DD)2.4± 6.1
3 months
GroupValue95% CI
Immediate Delivery (ID)0.7± 2.8
Delayed Delivery (DD)1.6± 4.6
6 months
GroupValue95% CI
Immediate Delivery (ID)1.3± 4.7
Delayed Delivery (DD)1.6± 5.4
9 months
GroupValue95% CI
Immediate Delivery (ID)0.8± 2.9
Delayed Delivery (DD)0.8± 3.4
Condomless Anal Intercourse Primary · baseline to 9-months post randomization

Reporting condomless anal intercourse in the past 30 days (yes/no)

Baseline
GroupValue95% CI
Immediate Delivery (ID)63
Delayed Delivery (DD)54
1 month
GroupValue95% CI
Immediate Delivery (ID)40
Delayed Delivery (DD)55
2 months
GroupValue95% CI
Delayed Delivery (DD)36
3 months
GroupValue95% CI
Immediate Delivery (ID)32
Delayed Delivery (DD)36
6 months
GroupValue95% CI
Immediate Delivery (ID)38
Delayed Delivery (DD)35
9 months
GroupValue95% CI
Immediate Delivery (ID)40
Delayed Delivery (DD)32
Condomless Anal Intercourse While High on Methamphetamine Primary · 9-months post randomization

Reporting condomless anal intercourse while high on methamphetamine in the past 30 days (yes/no)

Baseline
GroupValue95% CI
Immediate Delivery (ID)56
Delayed Delivery (DD)49
1 month
GroupValue95% CI
Immediate Delivery (ID)30
Delayed Delivery (DD)42
2 months
GroupValue95% CI
Delayed Delivery (DD)30
3 months
GroupValue95% CI
Immediate Delivery (ID)26
Delayed Delivery (DD)32
6 months
GroupValue95% CI
Immediate Delivery (ID)26
Delayed Delivery (DD)28
9 months
GroupValue95% CI
Immediate Delivery (ID)26
Delayed Delivery (DD)23
ART Initiation Secondary · 9-months post randomization

Starting to receive ART among HIV sero-positive participants who were not on ART at baseline (yes/no)

GroupValue95% CI
Immediate Delivery (ID)2
Delayed Delivery (DD)5
PrEP Initiation Secondary · 9-months post randomization

Starting to receive PrEP among HIV sero-negative participants who were not on PrEP at baseline (Yes/No)

GroupValue95% CI
Immediate Delivery (ID)4
Delayed Delivery (DD)7

Sponsor's own description

A commonly used manualized outpatient methamphetamine intervention for gay and bisexual men, "Getting Off," is being translated into a mobile phone application (i.e., app) available for download through common app marketplaces. The application will provide games, guided lessons, informational support, and resources to gay and bisexual men seeking to reduce their methamphetamine use and risky sexual behaviors.

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

  1. A Theory-Based mHealth Intervention (Getting Off) for Methamphetamine-Using Men Who Have Sex With Men: Protocol for a Randomized Controlled Trial.
    Reback CJ, Fletcher JB, Mata RP. · · 2021 · cited 9× · PMID 33616547 · DOI 10.2196/22572
  2. A Treatment Mobile App for Sexual Minority Men Who Use Methamphetamine Demonstrates Reductions in Methamphetamine Use and HIV Sexual Risk Behaviors: Getting Off.
    Reback CJ, Lin C, Li MJ, Fletcher JB, et al · · 2025 · PMID 40679728 · DOI 10.1007/s10461-025-04816-6
  3. Factors associated with placement along the HIV prevention and care continuum among sexual minority men who use methamphetamine.
    Reback CJ, Lin C, Li MJ. · · 2025 · PMID 40073428 · DOI 10.1080/09540121.2025.2473942

Verify or expand the search:

Other recruiting trials for Methamphetamine Abuse

Currently open trials in the same condition.

Other Friends Research Institute, Inc. trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03884946.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing