Kappa Opioid Receptor Antagonism for the Treatment of Alcohol Use Disorder (AUD) and Comorbid PTSD

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Protocol Title: Kappa Opioid Receptor Antagonism for the Treatment of Alcohol Use Disorder (AUD) and Comorbid PTSD 

Objective: Evaluate the efficacy and physiological effects of buprenorphine combined with naltrexone in the treatment of comorbid AUD and PTSD. 

Hypothesis:

Compared to the placebo group, a proportionally higher number of participants will respond to treatment with buprenorphine and naltrexone, with the primary efficacy endpoint being a reduction of both AUD and PTSD symptoms. 

Primary Inclusion Criteria: Treatment-seeking veterans and active duty service members with co-occurring PTSD and AUD.

Subject Completion Target: n = 135 subjects

Study Protocol: 

This Phase II Randomized Controlled Trial (RCT), has a 36-month study period, with a participant duration of 14 weeks from the time of randomization.

The participants are assessed for outcomes on weeks 1, 2, 4, 6, 8, 10, and 12. Primary and secondary efficacy endpoints are at week 8. At week 8, participants remain on the assigned drug or placebo for an additional 4 weeks to allow for a 12-week endpoint. Study medication is discontinued at week 12 and participants return at week 14 for evaluation of withdrawal side effects.

Testing for this study includes, but is not limited to: laboratory, psychophysiological studies, MINI International Neuropsychiatric Interview for DSM-5 (MINI-5), Clinical Institute Withdrawal Assessment of Alcohol Scale, Revise (CIWA-Ar), Alcohol Dependent Scale (ADS), Clinical Opiate Withdrawal Scale (COWS), Ohio State University Traumatic Brain Injury Identification Method- Short Form (OSU-TB), Barratt Impulsivity Scale (BIS), Life Events Checklist for DSM-5 (LEC-5), Timeline Follow Back (TLFB), Clinician-Administered PTSD Scale for ZDSM-5 (CAPS-5), and Columbia-Suicide Severity Rating Scale (C-SSRS).

Projected Study Timeline: 

Meeting & setup discussion: June – December 2018 

Begin contract & IRB process: January – April 2019

Subject enrollment period: April 2019 – March 2021


At a Glance

Study type:

 

Phase II Randomized Controlled Trial

Objective:

Evaluate the efficacy and physiological effects of buprenorphine with naltrexone in the treatment of comorbid AUD and PTSD.

Population:

Treatment-seeking veterans and active duty service members with comorbid AUD and PTSD

Number of Participants:

135

Data Collection:

Laboratory tests, Psychophysiological testing, and Outcome assessment tools (for measuring both AUD and PTSD)

Participating Site:

• Tuscaloosa Research & Education Advancement Corporation (TREAC)/Tuscaloosa VA Medical Center (TVAMC)
• Connecticut Research & Education Foundation (CREEF) / VA Connecticut Healthcare System (VACT)
• Atlanta Research and Education Foundation (AREF)/Atlanta VA Medical Center

Principal Investigator:

Lori Davis, MD and Ismene Petrakis, MD

Duration:

36 months