NCT03852628

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

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

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 69 (actual)
• Sponsor: Pharmacotherapies for Alcohol and Substance Use Disorders Alliance · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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)

Detailed description

Hypothesis: The treatment of (sublingual buprenorphine) SL-BUP + (extended release naltrexone) XR-NTX will significantly reduce both (alcohol use disorder) AUD and (post-traumatic stress disorder) PTSD symptoms. Primary Inclusion Criteria: Treatment-seeking individuals with comorbid AUD and PTSD Subject Completion Target: A total of 90 male and female, treatment-seeking individuals with comorbid AUD and PTSD screened, enrolled, and randomized to treatment group Study Protocol: Screening: Potential participants are pre-screened by phone to ensure they meet basic study criteria. During informed consent and screening processes, participants receive thorough pre-enrollment education and the commitment to and feasibility for follow-up are confirmed. Screening visit is separate (at least 2-day interval) from Baseline visit. A participant who is otherwise meeting eligibility criteria except for taking an excluded medication can undergo a medically supervised discontinuation and 5-day washout of medication(s). At any point in the screening process and based on the inclusion and exclusion criteria listed above, the participant may be deemed eligible and proceed to baseline visit or investigator may exclude a participant and refer him/her for appropriate treatment. At baseline, participants are randomized to receive either treatment A (buprenorphine 2mg SL with naltrexone 380mg IM) or treatment B (SL placebo and IM placebo) in a double-blind fashion. The treatment allocation ratio for the treatment vs. placebo regimens is 1:1. At Screening, Baseline and Follow-up, an independent rater at each site performs the Timeline Follow Back (TLFB), Clinician Administered PTSD Scale for DSM-5 (CAPS-5), and Columbia Suicide Severity Rating (CSSR) assessments. Safety endpoints, adverse events (AEs), vital signs, and laboratory measures are tracked for each subject to assess study drug safety.

Conditions

• Post Traumatic Stress Disorder
• Alcohol Abuse

Interventions

Type	Name	Description
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

Timeline

• Start date: 2019-05-20
• Primary completion: 2022-05-02
• Completion: 2023-01-30
• First posted: 2019-02-25
• Last updated: 2023-09-14
• Results posted: 2023-06-07

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated drug study