drugset / Trial / NCT03852628
Kappa Opioid Receptor Antagonism for the Tx of AUD and Comorbid PTSD
Phase 2
Terminated
69 enrolled
Pharmacotherapies for Alcohol and Substance Use Disorders Alliance
RTI International · collabUnited States Department of Defense · collab
RandomizedParallel-groupTriple-blindTreatment
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)
Timeline
- Start
- 2019-05-20
- Primary completion
- 2022-05-02
- Completion
- 2023-01-30
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Buprenorphine | Other / unclassified | 2 mg | Other |
| Comparator | Naltrexone | Small molecule | 380 mg | Intramuscular |