Kappa Opioid Receptor Antagonism for the Tx of AUD and Comorbid PTSD (NCT03852628) | Clinical Trial Compass
TerminatedPhase 2
Kappa Opioid Receptor Antagonism for the Tx of AUD and Comorbid PTSD
Stopped: Futility analysis
United States69 participantsStarted 2019-05-20
Plain-language summary
Objective: Evaluate the efficacy and physiological effects of sublingual buprenorphine (SL-BUP; Subutex) combined with extended-release injectable naltrexone (XR-NTX; Vivitrol) in the treatment alcohol use disorder of comorbid (AUD) and post-traumatic stress disorder (PTSD)
Who can participate
Age range18 Years – 70 Years
SexALL
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Inclusion criteria
✓. Male or female, 18 to 70 years of age, capable of reading and understanding English, and able to provide written informed consent (i.e. no surrogate).
✓. Current moderate to severe AUD as determined by MINI International Neuropsychiatric Interview for DSM-5 (MINI-5).
✓. At least two recent episodes of heavy drinking (\>5 standard drinks/sessions for men and \>4 standard drinks/sessions for women) over the past 30 days, and heavy drinking pattern defined as 14 drinks per week for women and 21 drinks per week for men for at least 2 of a 4-week interval within the 90 days prior to baseline; i.e. at least Moderate Risk level on WHO category.
✓. PTSD diagnosis defined by MINI-5 at screening.
✓. Clinician Administered PTSD Scale for DSM-5 (CAPS-5) total score ≥26 for the past week at baseline.
✓. Females of child-bearing potential must be using medically acceptable birth control (e.g. oral, implantable, injectable, or transdermal contraceptives; intrauterine device; double-barrier method) AND not be pregnant OR have plans for pregnancy or breastfeeding during the study.
✓. Must have a CIWA-Ar score of \< 8 prior to randomization.
✓. Willing and able to refrain from medications thought to influence alcohol consumption (other formulations of naltrexone, disulfiram, acamprosate, topiramate, ondansetron, and baclofen).
Exclusion criteria
✕. Current diagnosis of DSM-5 bipolar I, schizophrenia, schizoaffective, and/or major depressive disorder with psychotic features (defined by MINI-5 at screening).
What they're measuring
1
Number of Participants With a Reduction in Alcohol Use Disorder (AUD), With TLFB Tool
Timeframe: Baseline and 8 weeks
2
Number of Participants With a Reduction in CAPS-5 Total Symptom Severity Score (TSSS) of 10 or More Points
Timeframe: Baseline and 8 weeks
3
Composite Outcome Measure for a Reduction in Both Alcohol Use Disorder (AUD) and Post-Traumatic Stress Disorder (PTSD) Symptoms
Timeframe: Baseline and 8 Weeks
Trial details
NCT IDNCT03852628
SponsorPharmacotherapies for Alcohol and Substance Use Disorders Alliance
✕. Increased risk of suicide that necessitates inpatient treatment or warrants therapy excluded by the protocol, and/or current suicidal plan, per investigator clinical judgement, based on interview and defined on the Columbia Suicidality Severity Rating Scale (C-SSRS).
✕. Treatment with trauma-focused therapy for PTSD (e.g. Cognitive Processing Therapy, Prolonged Exposure, or EMDR) within two weeks of baseline study visit. Note: Supportive psychotherapy in process for PTSD at time of Screening may be continued.
✕. Current diagnosis of severe non-alcohol substance use disorder (except for caffeine and nicotine) during the preceding 1 month, based on participant screening interview.
✕. Use of opioids within 2 weeks of baseline or opioid use disorder in the previous 90 days.
✕. History of severe traumatic brain injury (TBI) per Ohio State University TBI Identification Method. Note: history of mild or moderate TBI is allowed.
✕. Any clinically significant, uncontrolled, or medical/surgical condition that would contraindicate use of SL-BUP + XR-NTX, or limit ability to complete study assessments, including seizures (other than childhood febrile seizures), severe renal insufficiency, significant arrhythmia or heart block, heart failure, or myocardial infarction within the past 2 years, severe thrombocytopenia or hemophilia, severe hepatic failure, complete hearing loss, and/or need for surgery that might interfere with ability to participate.
✕. Clinically significant laboratory abnormalities, including a thyroid stimulating hormone (TSH) \>1.5 times upper limit of normal, hyperthyroidism, and aspartate aminotransferase and/or alanine aminotransferase \> 3 times upper limit of normal; cardiovascular findings QTcF \>500 msec on electrocardiogram (ECG) or blood pressure \>190/110.