ChemsexACT-for-chemseNCT06980974
Acceptance and Commitment Therapy for Chemsex
A study testing ACT-for-chemsex and Treatment as Usual (TAU) in people with Chemsex, run by University of Alabama at Birmingham at 1 site in United States.
Trial summary
Quasi-randomized control trial of acceptance and commitment therapy (ACT) for chemsex. Read more about this study
- Who is it for?
- Ages 18 to 65 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Chemsex
- What is being tested?
- ACT-for-chemsex and Treatment as Usual (TAU)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Dec 2025to 31 Dec 2030
- 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 to 65 years
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Alabama at Birmingham
Birmingham, Alabama, 35233
About this study
Official title: Quasi-Randomized Controlled Trial of Acceptance and Commitment Therapy for Chemsex
Quasi-randomized control trial of acceptance and commitment therapy (ACT) for chemsex.
Read the detailed description
Intervention will entail a prescreening, intake session, 16 therapy sessions, and a six-month follow-up. Each session will be 45-55 minutes long. Participants in ACT-for-chemsex will be compared to participants in a treatment as usual condition.
- Conditions
- Chemsex
- Being tested
- ACT-for-chemsex, Treatment as Usual (TAU)
- Keywords
- chemsex, ACT
- Medical subject headings
- Chemsex
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ACT-for-chemsexBehavioural
16 weeks of acceptance and commitment therapy, delivered online weekly, 45-55 minute sessions
Treatment as Usual (TAU)Other
Participants in TAU will receive health/mental health interventions as needed
| Study group | Role | What they receive |
|---|---|---|
| ACT-for-chemsex | Experimental | 16 weeks of ACT to reduce chemsex Receives: Behavioral: ACT-for-chemsex |
| Treatment as usual | Active comparator | Treatment as usual Receives: Other: Treatment as Usual (TAU) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Chemsex frequency
Self-reported chemsex frequency in the past six months
Measured: Baseline, 16 week post-treatment, six month follow-up
Secondary outcomes (9)
Modified NIDA ASSIST
Past six month substance use on the following scale 0=never
- Once or Twice
- Monthly
- Weekly
- Daily or Almost Daily
Measured: Baseline, 16 week post-treatment, six month follow-up
Sexual Health History
Questions will inquire about STI status including a lifetime history and past 12-month diagnostic status for the following STIs: HIV, Gonorrhea, Syphilis, Chlamydia, Hepatitis C, and Genital Herpes. Participants will be asked "In the past year, have you taken PrEP (pre-exposure prophylaxis)?" ("0=No", "1=Yes, Daily PrEP", "2=Yes, On-Demand [2-1-1] PrEP", "3=Yes, Long-acting PrEP", "4=Not sure"). We will include ad-hoc measures commonly used in previous studies for single item assessments of lifetime, past year, past month, and past week number of partnered sexual experiences, sexual partners, and age of first partnered sexual experience. We will also include the ID Risk Behavior (BRAID) scale (e.g., "Had unprotected [no condom] sex with someone who was a one-night stand or someone you had just met?" "yes", "no"), sexual violence questions as recommended by the Centers for Disease Control and Prevention YRCSS standard national questionnaire.
Measured: Baseline
Center for epidemiologic studies depression scale
A series of questions asking about depression symptoms (e.g. " I was bothered by things that usually don't bother me ")
On the following scale:
0=Rarely or none of the time (less than 1 day)
- Some or a little of the time (1-2 days)
- Occasionally or a moderate amount of the time (3-4 days)
- Most or all of the time (5-7 days)
Measured: Baseline, 16 week post-treatment, six month follow-up, every two weeks.
generalized anxiety disorder-7
Anxiety measure.
Over the last two weeks, how often have you been bothered by the following problems?
e.g. "Feeling nervous, anxious, or on edge"
0=not at all
- several days
- more than half the days
- nearly every day
Measured: Baseline, 16 week post-treatment, six month follow-up, every two weeks
Experiential Avoidance Rating Scale
A series of questions asking about experiential avoidance symptoms (e.g. "I have gone to extremes to get rid of thoughts I don't like.")
Measured: Baseline, 16 week post-treatment, six month follow-up
PSY Flex
A series of questions asking about psychological flexibility (e.g. "Even if I am somewhere else with my thoughts, I can focus on what's going on in important moments.")
Measured: Through study completion, an average of one a week"
Patient Checklist-5
A series of questions asking about PTSD symptoms (e.g. " Repeated, disturbing, and unwanted memories of the stressful experience? ")
Measured: Baseline, 16 week post-treatment, six month follow-up
Quality of Life Scale
A series of questions asking about quality of life (e.g. " Relations with parents, siblings, other relatives")
Measured: Baseline, 16 week post-treatment, six month follow-up
Multidimensional Psychological Flexibility Inventory
A series of questions asking about psychological flexibility (e.g. " I was receptive to observing unpleasant thoughts and feelings without interfering with them.")
Measured: Baseline, 16 week post-treatment, six month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2025
- Study start1 Dec 2025 (estimated)
- Primary completion31 Jul 2030 (estimated)
- Study completion31 Dec 2030 (estimated)
Why it stopped: Funding not received.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ChemsexStudies of the same condition, open and under way.
- More trials run by University of Alabama at BirminghamThe 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
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alabama at Birmingham
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nicholas C. Borgogna, University of Alabama at Birmingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06980974
- Sponsor's protocol ID
- IRB-300014764
- Acronym
- ACT-for-chemse
- Status last verified
- Dec 2025
- First submitted
- 21 Apr 2025
- Last updated
- 15 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Deidentified data will be shared with the research community for secondary analysis. Data can be accessed by emailing the PI.
Study at a glance
From the registry record, last updated by the sponsor on 15 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Quasi-Randomized Controlled Trial of Acceptance and Commitment Therapy for Chemsex
- ClinicalTrials.gov ID
- NCT06980974
- Acronym / sponsor ID
- ACT-for-chemse / IRB-300014764
- Conditions
- Chemsex
- Keywords
- chemsex, ACT
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Funding not received.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of Alabama at BirminghamUniversity, hospital or other
- Study start
- 1 Dec 2025 (estimated)
- Primary completion
- 31 Jul 2030 (estimated)
- Study completion
- 31 Dec 2030 (estimated)
- First posted
- 20 May 2025 (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.
Quasi-randomized control trial of acceptance and commitment therapy (ACT) for chemsex.
Detailed description
Intervention will entail a prescreening, intake session, 16 therapy sessions, and a six-month follow-up. Each session will be 45-55 minutes long. Participants in ACT-for-chemsex will be compared to participants in a treatment as usual condition.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ACT-for-chemsex | Experimental | Behavioral: ACT-for-chemsex16 weeks of ACT to reduce chemsex |
| Treatment as usual | Active comparator | Other: Treatment as Usual (TAU)Treatment as usual |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (8 listed)
- Psychotic disorder
- bipolar disorder
- eating disorder
- major neurocognitive disorder diagnosis
- self-harm or suicide attempt within 12 months of screener
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 |
|---|---|---|
| ACT-for-chemsex16 weeks of acceptance and commitment therapy, delivered online weekly, 45-55 minute sessions | Behavioural | ACT-for-chemsex |
| Treatment as Usual (TAU)Participants in TAU will receive health/mental health interventions as needed | Other | Treatment as usual |
Primary outcome
Chemsex frequency
Time frame: Baseline, 16 week post-treatment, six month follow-up
Self-reported chemsex frequency in the past six months
9 secondary outcomes
Modified NIDA ASSIST
Time frame: Baseline, 16 week post-treatment, six month follow-up
Sexual Health History
Time frame: Baseline
Center for epidemiologic studies depression scale
Time frame: Baseline, 16 week post-treatment, six month follow-up, every two weeks.
generalized anxiety disorder-7
Time frame: Baseline, 16 week post-treatment, six month follow-up, every two weeks
Experiential Avoidance Rating Scale
Time frame: Baseline, 16 week post-treatment, six month follow-up
PSY Flex
Time frame: Through study completion, an average of one a week"
Patient Checklist-5
Time frame: Baseline, 16 week post-treatment, six month follow-up
Quality of Life Scale
Time frame: Baseline, 16 week post-treatment, six month follow-up
Multidimensional Psychological Flexibility Inventory
Time frame: Baseline, 16 week post-treatment, six month follow-up
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Dec 2025.
- Individual participant dataSharing planned: Yes. Deidentified data will be shared with the research community for secondary analysis. Data can be accessed by emailing the PI.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ACT-for-chemsex and Treatment as Usual (TAU) in people with Chemsex, run by University of Alabama at Birmingham at 1 site 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 8 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: withdrawn, as of the sponsor's last update on 15 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 was withdrawn before enrolling participants, so there are no results.
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?
Chemsex frequency (time frame: Baseline, 16 week post-treatment, six month follow-up). 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 15 Dec 2025.