Optimal Treatment of Veterans With PTSD and Comorbid Opiate Use Disorder (OUD)

MHBB-010-17F

The objective of this study is to test a standard psychotherapy for PTSD in Veterans who also suffer from Opiate Use Disorder (OUD). Specifically, this study will test whether Cognitive Processing Therapy (CPT)-C is more effective in treating PTSD, compared to a control group (Individual Drug Counseling (IDC); which approximates treatment as usual), among Veterans with PTSD and comorbid OUD who are maintained on buprenorphine. The study has three phases. In Phase I: induction to buprenorphine/naloxone (BUP/NLX) maintenance. Phase II: treatment. During this phase participants will be randomly assigned to CPT-C or IDC for 12 weeks. They will be seen weekly for psychotherapy and also regularly (weekly, then biweekly, then monthly) for buprenorphine management, symptom evaluation, and medication refill. After completing treatment participants will be referred to a buprenorphine clinic for ongoing care. Phase III: follow-up. Approximately 160 male and female Veterans (18-65 years old) with PTSD and comorbid opiate use disorder (OUD) will be enrolled in this study. Recruitment will be through VA clinics, word-of-mouth, referrals from area programs and by advertisement. Veterans who are interested will complete a brief pre-screening and detailed in-person screening. After completing the screening process, all eligible participants will be started on buprenorphine maintenance and once withdrawal symptoms are stabilized, participants will be randomly assigned to 1 of 2 conditions (CPT-C or IDC) for 12 weeks. Veterans who are already on BUP/NLX will be allowed to participate and will start at Phase II of the study, after completing the screening.

2018-10-01

2023-04-14

2023-04-14

Terminated

Early phase I

37

Inclusion Criteria: * Current diagnosis of PTSD as determined by an independent evaluator assessment using CAPS-5. * Opioid Use Disorder diagnosed by Structured Clinical Interview for DSM-5 (SCID-V) * To meet entry criteria for buprenorphine treatment: * will also have documented prior treatment for opioid use disorder * history of opioid withdrawal or signs of opiate withdrawal as evidenced by a Clinical Opiate Withdrawal Scale (COWS) score of 7 or greater * a positive urine toxicology for opioids * Medically and neurologically healthy on the basis of: * history * physical examination * EKG * screening laboratories (CBC w/ differential, TSH, Free-T4, ASAT, ALAT, GGT, BUN, creatinine, calcium, phosphorous, magnesium, total protein, albumin, electrolytes, urinalysis, urine toxicology, beta-HCG) * For women, negative pregnancy test and use of acceptable method of contraception Exclusion Criteria: * Females who are pregnant or lactating * Veterans with a current unstable medical condition such as: * neurological * cardiovascular * endocrine * renal * liver * or thyroid pathology (e.g. abnormal BUN and creatinine, and unmanaged hypertension with BP \> 200/120) which in the opinion of the physician would preclude the patient from fully cooperating or be of potential harm during the course of the study * Veterans who meet current criteria for the following diagnoses (bipolar disorders, schizophrenia and schizophrenia spectrum and psychotic disorders) as determined by the SCID-V * Veterans who have significant current suicidal or homicidal risks necessitating a higher level of care * Those with known allergy or intolerance to buprenorphine

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'interventionModelDescription': "This study is a 14-week, open-label randomization: 1) buprenorphine (BUP) + CPT-C vs (2) BUP + IDC. Phase I: buprenorphine induction and stabilization for all participants. Participants starting dose 2mg/0.5 mg BUP/NLX this will increased as needed up to 24 mg per day. Phase II: randomization to CPT vs. IDC (x12 weeks). CPT-C will be provided by one of the investigators' licensed therapists trained. IDC will be provided by research staff. Phase III: Subjects will be referred to one of the buprenorphine clinics (West Haven or Newington) and will be referred for ongoing treatment for PTSD if they choose, including the option for CPT-C for those who did not receive this during the study. Participants will be seen on a daily basis (excluding weekends) for the initial 5-7 day induction. Once subjects are on maintenance dose of BUP/NLX, they will be seen weekly by study RN for the first 4 weeks, biweekly for a month then monthly for symptom evaluation, and medication refill.", 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'SINGLE', 'maskingDescription': "To fully assess and appreciate complex symptomatology in this patient population, assessments were selected to have both relevance to the investigators' study of PTSD and comorbid OUD. Assessments will be done by an Independent Evaluator (IE) blind to treatment group.", 'whoMasked': ['OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 37, 'type': 'ACTUAL'}}

2023-11-03