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Kappa Opioid Receptor Antagonism for the Tx of AUD and Comorbid PTSD

NCT03852628 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 69

Last updated 2023-09-14

Study results available
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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)

Conditions

  • Post Traumatic Stress Disorder
  • Alcohol Abuse

Interventions

DRUG

2mg Buprenex and 380mg Vivitrol

Daily 2mg SL BUP (84 pills total, taken sublingual every day for 12 weeks) and Q4wks (given intramuscular, 3 injections total: at baseline, week4 and week8 ) IM NLTRX

DRUG

Placebo (SL pill qd, IM injection q4weeks)

Daily SL placebo (84 pills total, taken sublingual every day for 12 weeks) and Q4wks (given intramuscular, 3 injections total: at baseline, week4 and week8) IM Placebo

Sponsors & Collaborators

  • United States Department of Defense

    collaborator FED

  • RTI International

    collaborator OTHER

  • Pharmacotherapies for Alcohol and Substance Use Disorders Alliance

    lead OTHER

Principal Investigators

  • Lori Davis · Associate Chief of Staff, Research & Development Service VA Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-05-20
Primary Completion
2022-05-02
Completion
2023-01-30
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03852628 on ClinicalTrials.gov