NCT06980974

Brief Summary

Quasi-randomized control trial of acceptance and commitment therapy (ACT) for chemsex.

Trial Health

50
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Timeline
57mo left

Started Dec 2025

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress9%
Dec 2025Dec 2030

First Submitted

Initial submission to the registry

April 21, 2025

Completed
29 days until next milestone

First Posted

Study publicly available on registry

May 20, 2025

Completed
7 months until next milestone

Study Start

First participant enrolled

December 1, 2025

Completed
4.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2030

Expected
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2030

Last Updated

December 15, 2025

Status Verified

December 1, 2025

Enrollment Period

4.7 years

First QC Date

April 21, 2025

Last Update Submit

December 5, 2025

Conditions

Keywords

chemsexACT

Outcome Measures

Primary Outcomes (1)

  • Chemsex frequency

    Self-reported chemsex frequency in the past six months

    Baseline, 16 week post-treatment, six month follow-up

Secondary Outcomes (9)

  • Modified NIDA ASSIST

    Baseline, 16 week post-treatment, six month follow-up

  • Sexual Health History

    Baseline

  • Center for epidemiologic studies depression scale

    Baseline, 16 week post-treatment, six month follow-up, every two weeks.

  • generalized anxiety disorder-7

    Baseline, 16 week post-treatment, six month follow-up, every two weeks

  • Experiential Avoidance Rating Scale

    Baseline, 16 week post-treatment, six month follow-up

  • +4 more secondary outcomes

Study Arms (2)

ACT-for-chemsex

EXPERIMENTAL

16 weeks of ACT to reduce chemsex

Behavioral: ACT-for-chemsex

Treatment as usual

ACTIVE COMPARATOR

Treatment as usual

Other: Treatment as Usual (TAU)

Interventions

ACT-for-chemsexBEHAVIORAL

16 weeks of acceptance and commitment therapy, delivered online weekly, 45-55 minute sessions

ACT-for-chemsex

Participants in TAU will receive health/mental health interventions as needed

Treatment as usual

Eligibility Criteria

Age18 Years - 65 Years
Sexmale(Gender-based eligibility)
Gender Eligibility DetailsMale (as assigned at birth)
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Male
  • age 18-65
  • access to internet capable smart device
  • documentation of Alabama residence
  • access to a private area to attend tele ACT-for-chemsex sessions
  • self-reported chemsex within six-months of intake
  • English fluency.

You may not qualify if:

  • Psychotic disorder
  • bipolar disorder
  • eating disorder
  • major neurocognitive disorder diagnosis
  • self-harm or suicide attempt within 12 months of screener
  • suicide plan/intention at time of screening
  • ongoing treatment for a complex medical comorbidity (e.g., in patient cancer treatment)
  • current enrollment in an individual ACT-based psychotherapy intervention.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Alabama at Birmingham

Birmingham, Alabama, 35233, United States

Location

MeSH Terms

Conditions

Chemsex

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

Sexual BehaviorBehavior
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

April 21, 2025

First Posted

May 20, 2025

Study Start

December 1, 2025

Primary Completion (Estimated)

July 31, 2030

Study Completion (Estimated)

December 31, 2030

Last Updated

December 15, 2025

Record last verified: 2025-12

Data Sharing

IPD Sharing
Will share

Deidentified data will be shared with the research community for secondary analysis. Data can be accessed by emailing the PI.

Shared Documents
ANALYTIC CODE
Time Frame
1/1/2031 - 1/1/2035
Access Criteria
Researchers affiliated with Academic institutions.

Locations