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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT05709353
Registration number
NCT05709353
Ethics application status
Date submitted
20/01/2023
Date registered
2/02/2023
Date last updated
7/11/2023
Titles & IDs
Public title
MDMA-assisted Prolonged Exposure Therapy for Comorbid Alcohol Use Disorder and Post-traumatic Stress Disorder
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Scientific title
A Randomised, Controlled Trial of MDMA-assisted Prolonged Exposure Therapy for Comorbid Alcohol Use Disorder and Post-traumatic Stress Disorder
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Secondary ID [1]
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X22-0121
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Universal Trial Number (UTN)
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Trial acronym
MPATHY
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
PTSD
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Alcohol Use Disorder
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Alcohol Dependence
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Post-traumatic Stress Disorder
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Comorbidities and Coexisting Conditions
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Condition category
Condition code
Mental Health
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Addiction
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Mental Health
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Anxiety
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Mental Health
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Other mental health disorders
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Other
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Research that is not of generic health relevance and not applicable to specific health categories listed above
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Mental Health
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Depression
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Behaviour - Prolonged exposure therapy
Treatment: Drugs - MDMA
Treatment: Drugs - Niacin
Experimental: COPE + MDMA - 4x COPE sessions
Dose 1:
2x MDMA capsules (80mg) + 1x niacin-matched placebo capsule
Optional supplementary dispense:
1x MDMA capsule (40mg)
4x COPE sessions
Dose 2:
2x MDMA capsules (80mg) + 1x niacin-matched placebo capsule
Optional supplementary dispense:
1x OR 2x white MDMA capsule (40 or 80mg)
4x COPE sessions
Other: COPE + Niacin (Control) - 4x COPE sessions
Dose 1:
2x MDMA-matched placebo capsules + 1x niacin capsule (250mg)
Optional supplementary dispense:
1x MDMA-matched placebo capsule
4x COPE sessions
Dose 2:
2x MDMA-matched placebo capsules + 1x niacin capsule (250mg)
Optional supplementary dispense:
1x OR 2x MDMA-matched placebo capsule
4x COPE sessions
Behaviour: Prolonged exposure therapy
COPE represents an integration of existing evidence-based manualised CBT interventions for PTSD and substance dependence (see manual DOI: 10.1093/med:psych/9780199334513.001.0001). COPE used in the current study will represent an integration of existing evidence-based manualised CBT interventions for PTSD and substance dependence. COPE only begins when the participant in a safe environment and no longer in contact with the traumatic event/exposure.
COPE employs imaginal and in vivo exposures to treat PTSD and consists of 12 individual 90-minute sessions (i.e. 19.5 hours) delivered by a clinical psychologist.
Treatment: Drugs: MDMA
Administration of 80 to 160 mg MDMA across two 'dosing' sessions. Supplemental doses (additional 40mg during first session, additional 40- 80mg during second session) will be dependent on clinician and participant consensus during preparatory period of 'dosing session'. These supplemental amounts will be dispensed 60 to 90 minutes after initial 80 mg dose.
Treatment: Drugs: Niacin
Administration of niacin 250mg or niacin-matched placebo during two 'dosing' sessions.
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Intervention code [1]
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Behaviour
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Intervention code [2]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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change in clinician-rated PTSD severity via Clinician-Administered PTSD Scale for DSM-5 (Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition) (CAPS-5) from baseline to visit 16.
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Assessment method [1]
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CAPS-5 is a structured diagnostic interview with excellent psychometric properties and diagnostic efficiency and used widely in MDMA-assisted PTSD studies. The CAPS-5 will be administered by independent evaluators blind to treatment condition.
CAPS-5 total symptom severity score is calculated by summing severity scores for the 20 DSM-5 PTSD symptoms.
CAPS-5 symptom cluster severity scores are calculated by summing the individual item severity scores for symptoms corresponding to a given DSM-5 cluster: Criterion B (items 1-5); Criterion C (items 6-7); Criterion D (items 8-14); and, Criterion E (items 15-20).
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Timepoint [1]
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52 weeks
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Primary outcome [2]
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change in self-reported PTSD symptom severity via Post-Traumatic Stress Disorder Checklist for DSM-5 (Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition) (PCL-5) from baseline to visit 16.
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Assessment method [2]
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PCL-5 has excellent psychometric characteristics for a secondary indicator of PTSD symptom severity.
Items are summed to provide a total severity score (range = 0-80). The PCL-5 can determine a provisional diagnosis in two ways: Summing all 20 items (range 0-80) and using a cut-point score of 31-33 appears to be reasonable based upon current psychometric work.
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Timepoint [2]
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52 weeks
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Secondary outcome [1]
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Number of Heavy Drinking Days per week (HDDs) (>5 standard drinks/day for men; >4 for women)
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Assessment method [1]
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This will be measured by the Timeline Follow Back and corroborated with Phosphatidylethanol (PEth) levels
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Timepoint [1]
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52 weeks
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Secondary outcome [2]
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Absence of any HDD
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Assessment method [2]
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Measured by Timeline Follow Back and corroborated with Phosphatidylethanol (PEth) levels
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Timepoint [2]
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52 weeks
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Eligibility
Key inclusion criteria
1. Both AUD and current PTSD according to the DSM-5 criteria, for 6 months or longer with
at least moderate severity, according to investigator judgement and CAPS-5
2. Aged =18 years old
3. Adequate cognition and English language skills to give valid consent and complete
research interviews assessments
4. Willing to give written informed consent
5. Received prior treatment for PTSD or AUD (not including study interventions)
6. Stable housing
7. Able to identify a significant other (such as a family/friend/partner) who could
accompany them from clinic/provide transport and/or be contacted by the study team if
required
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
1. History of, or currently meeting, DSM-5 criteria for:
- current or lifetime psychotic or bipolar disorders, or
- major depression with psychotic features Assessed via Structured Clinical
Interview for DSM-5 - Research Version (SCID-5-RV). Potential participants will
be screened for personality disorders but suitability will then be confirmed by
clinical interview given the prevalence of high scores in this comorbid
population
2. Pregnant or lactating (contraception must be used and a sensitive pregnancy test will
be performed at baseline and prior to dosing)
3. Significant alcohol withdrawal (current Clinical Institute Withdrawal Assessment for
Alcohol [CIWA-Ar] score =10, including history of delirium tremens or alcohol
withdrawal seizures).
4. Concurrent use of psychotropic medication (antidepressants and alcohol pharmacotherapy
use considered if assessed by physician and titrated down with 5 half-lives + 1 week
washout)
5. Use of, and unable or unwilling to cease, any medications likely to interact with MDMA
in the opinion of the physicians and investigators during the trial (low dose opiates
are permitted for pain management but not the night before or after MDMA sessions)
6. Substance use disorder other than tobacco (e.g. benzodiazepines, cannabis)
7. Abnormal clinical findings including a history of, or current: cardiac disease and/or
dysrhythmia, uncontrolled hypertension or severe hypotension, abnormal
electrocardiogram findings, stroke, liver disease, a history of epilepsy,
hyponatraemia, or malignant hyperthermia (controlled hypertension and diabetes type II
may be permitted)
8. Suicide risk according to clinician judgement and responses to Columbia Suicide
Severity Rating Scale-Lifetime (C-SSRS-L) and SCID-5-RV.
• Details surrounding any previous attempts >6 months ago will be gathered whereby
attempts related to their trauma/PTSD and/or associated with the use of
psychostimulants will contribute to risk assessment and guide trial safety measures if
enrolled
9. Clinically unstable systemic medical (e.g., cancer) or psychiatric disorder or
condition that might require hospitalisation that precludes trial participation
10. Regular use of ecstasy (e.g. at least twice in last 6 months, or >10 times within the
last 5 years)
11. Enrolled in any other interventional clinical trials in the previous two months or
over the duration of the study
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 2
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Recruiting
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
19/09/2023
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
1/05/2026
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Actual
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Sample size
Target
120
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
NSW,VIC
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Recruitment hospital [1]
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Drug Health Services, Royal Prince Alfred Hospital - Sydney
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Recruitment hospital [2]
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Turning Point - Richmond
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Recruitment postcode(s) [1]
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2050 - Sydney
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Recruitment postcode(s) [2]
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3121 - Richmond
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Funding & Sponsors
Primary sponsor type
Other
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Name
University of Sydney
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Address
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Country
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Other collaborator category [1]
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Other
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Name [1]
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Monash University
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Address [1]
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Country [1]
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Other collaborator category [2]
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Other
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Name [2]
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Sydney Local Health District
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Address [2]
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Country [2]
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Ethics approval
Ethics application status
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Summary
Brief summary
To explore the effectiveness of of MDMA-assisted prolonged exposure therapy in improving
treatment outcomes for individuals with comorbid PTSD and alcohol use disorder in a
double-blind randomised placebo-controlled trial.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT05709353
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Kirsten C Morley, PhD
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Address
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University of Sydney
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Kirsten C Morley, PhD
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Address
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Country
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Phone
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61295153636
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Fax
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Email
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[email protected]
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT05709353
Download to PDF