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Opioid Agonist

Buprenorphine + IDC for Post-Traumatic Stress Disorder

Phase 2
Waitlist Available
Led By Ismene L. Petrakis, MD
Research Sponsored by VA Office of Research and Development
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, week 6, week 12
Awards & highlights

Study Summary

This trial will test whether CPT-C, a standard psychotherapy, is more effective in treating PTSD than a control group among Veterans with PTSD and comorbid OUD who are maintained on buprenorphine.

Eligible Conditions
  • Post Traumatic Stress Disorder
  • Opioid Use Disorder

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, week 6, week 12
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, week 6, week 12 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Clinician Administered PTSD Scale CAPS-5 Change
PTSD Checklist - Military version (PCL-5) Change

Trial Design

2Treatment groups
Active Control
Group I: Buprenorphine + IDCActive Control2 Interventions
Buprenorphine induction and stabilization for all participants (x1 week). Participants will be started at a dose of 2mg/0.5 mg BUP/NLX and this dose will be increased as needed for stabilization of opioid withdrawal symptoms up to 24 mg per day, then IDC for 12 weeks
Group II: Buprenorphine + CPT-CActive Control2 Interventions
Buprenorphine induction and stabilization for all participants (x1 week). Participants will be started at a dose of 2mg/0.5 mg BUP/NLX and this dose will be increased as needed for stabilization of opioid withdrawal symptoms up to 24 mg per day, then CPT-C for 12 weeks.

Find a Location

Who is running the clinical trial?

VA Office of Research and DevelopmentLead Sponsor
1,606 Previous Clinical Trials
3,305,978 Total Patients Enrolled
Ismene L. Petrakis, MDPrincipal InvestigatorVA Connecticut Healthcare System West Haven Campus, West Haven, CT
2 Previous Clinical Trials
1,051 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are participants being recruited for this experiment at this time?

"That is accurate. According to clinicaltrials.gov, this trial was originally posted on October 1st 2018 and is still recruiting patients. The study needs around 160 participants from 2 locations."

Answered by AI

Might I be able to help with this research project?

"Eligible patients must have the disease and be of ages 18-65. There are approximately 160 spots available in the study."

Answered by AI

Has the Food and Drug Administration given their blessing to Buprenorphine + CPT-C?

"Buprenorphine + CPT-C is in Phase 2 of clinical trials, meaning that while there is evidence suggesting it is safe, none of the data collected thus far has been promising enough to suggest efficacy."

Answered by AI

Are there any previous cases of research on Buprenorphine + CPT-C?

"At the moment, 44 ongoing clinical trials are researching Buprenorphine + CPT-C. Out of these, 12 have reached Phase 3. Most of the research surrounding Buprenorphine + CPT-C is based in Durham, North carolina; however, there are 228 total locations conducting trials for this medication."

Answered by AI

How many people are signed up to participate in this research project?

"Yes, as specified on clinicaltrials.gov, this trial is currently looking for 160 patients from 2 locations. The first posting was on October 1st, 2018 and the most recent update was on April 6th, 2022."

Answered by AI

Is this study open to people who are over 25 years old?

"According to the inclusion criteria, patients who are eligible for this trial fall between 18-65 years of age. There are currently 301 clinical trials underway for individuals below 18 and 923 for those above 65."

Answered by AI
~6 spots leftby Mar 2025