MDMA for AUD/PTSD Comorbidity

Part of paid clinical trials in Providence, Rhode Island.

Sponsor
Carolina L Haass-Koffler
Study ID
NCT05943665
Phase
PHASE2
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • MDMA — DRUG
    medication and therapy combined

Study Details

The study investigators are conducting the first open label pilot trial of MDMA-assisted therapy (MDMA-AT) with a comorbid sample of military veterans with a comorbid diagnosis of Alcohol Use Disorder (AUD) and Post-Traumatic Stress Disorder (PTSD). This novel experimental treatment package consists of two once-monthly Experimental Sessions of therapy combined with a divided-dose of MDMA HCl, along with non-drug preparatory and integrative therapy. The Primary Outcome measure, the Timeline Follow-back (TLFB), will evaluate changes in alcohol use over time. Changes in PTSD symptoms will also be evaluated.

Key Dates

Start date
Feb 6, 2024
Status verified
Feb 2025
Primary completion
Jan 21, 2026
Completion
Jan 30, 2026

Study Design

Enrollment
18 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: MDMA-AT
    Participant will receive MDMA administration with assisted therapy (AT) by trained clinicians

Primary Outcome Measure

Number of standard unit drinks form the TLFB [ Time Frame: From baseline to post-treatment follow up (18 weeks) ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Brown UniversityProvidenceRhode Island02903
Brian Gully, MA
[email protected]
401-863-6646

Find similar trials in Providence, RI

By condition
Substance use disorderPTSD (post-traumatic stress disorder)
By specialty
Behavioral healthAddiction medicinePsychiatryMental health
By research site
Brown University· Providence, RI

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