Optimal Treatment of Veterans With PTSD and Comorbid Opiate Use Disorder (OUD)
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 38
- 试验地点
- 2
- 主要终点
- Clinician Administered PTSD Scale (CAPS-5)
研究概览
简要总结
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.
详细描述
The purpose of this study is to test whether Cognitive Processing Therapy (CPT-C) is more effective than Individual Drug Counseling (IDC), which is standard counseling, for the treatment of PTSD among Veterans with PTSD and comorbid opioid use disorder who are also maintained on buprenorphine. The investigators propose to conduct a randomized, controlled trial and Veterans (n=160) diagnosed with PTSD and comorbid OUD will be randomized to one of 2 groups: (a) buprenorphine and CPT-C or (b) buprenorphine and IDC (treatment as usual).
Primary Aim 1:.To test whether CPT-C is more effective than IDC in treating symptoms of PTSD among Veterans with OUD maintained on buprenorphine. PTSD symptoms will be measured using the PTSD Checklist - Military version (PCL-5) and confirmed by the Clinician Administered PTSD Scale using the Diagnostic and Statistical Manual of Mental Disorders (DSM-5) criteria (CAPS-5).
Secondary Aim 1: To test whether CPT-C is more effective than IDC in reducing opioid use among Veterans with PTSD and comorbid OUD maintained on buprenorphine. Opioid use will be measured using the Timeline Follow-back (TLFB) and confirmed by urine toxicology results.
Exploratory Aims: To examine if treatment groups differ in 1) retention, measured by days in treatment, 2) psychosocial functioning, measured by the Veterans RAND 12-Item Short Form Health Survey (VR-12), 3) sleep as measured by the Insomnia Severity Index (ISI), since sleep disturbance is a hallmark of PTSD and during early abstinence from opioids, and 4) Because of the high comorbidity between PTSD and chronic pain the investigators will explore this relationship and will measure pain intensity (measured by the Numeric Rating Scale (NRS), and functional impairment using the Patient-Reported Outcomes Measurement Information System (PROMIS-29) longitudinally over the course of treatment. Follow up will be conducted 1 and 3 months after completion of the study to evaluate durability of effect on PTSD symptoms (measured as changes in PTSD symptoms), opioid use and treatment utilization.
This study will be a randomized, open-label clinical trial. 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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
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.
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Current diagnosis of PTSD as determined by an independent evaluator assessment using CAPS-
- •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:
- •physical examination
- •screening blood tests (CBC w/ differential, Thyroid-stimulating hormone (TSH), Free-T4, aspartate aminotransferase (AST), alanine aminotransferase (ALAT), Gamma-glutamyl transferase (GGT), blood urea nitrogen (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
排除标准
- •Females who are pregnant or lactating
- •Veterans with a current unstable medical condition such as:
- •neurological
- •cardiovascular
- •endocrine
- •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
研究组 & 干预措施
Buprenorphine + CPT-C
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.
干预措施: Buprenorphine (Drug)
Buprenorphine + CPT-C
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.
干预措施: Cognitive Processing Therapy (CPT) (Behavioral)
Buprenorphine + IDC
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
干预措施: Buprenorphine (Drug)
Buprenorphine + IDC
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
干预措施: Individual Drug Counseling (IDC) (Behavioral)
结局指标
主要结局
Clinician Administered PTSD Scale (CAPS-5)
时间窗: Week 12
Clinician-Administered PTSD Scale for Diagnostic and Statistical Manual of Mental Disorders (DSM-5) (CAPS-5) is a structured diagnostic interview. The scale also assesses social and occupational functioning, dissociation symptoms, and the validity of symptom reports. The CAPS-5 uses a single 5-point ordinal rating scale to measure symptom severity. Symptom severity ratings combine information about symptom frequency and intensity obtained by the interviewer. The CAPS-5 requires approximately 40 minutes to administer. Scores can range from 0 (minimum score) - 80 (maximum score) with higher scores indicating greater severity. (0-19=Asymptomatic/few symptoms very mild PTSD, 20-39=Sub-threshold/mild PTSD, 40-59=Threshold PTSD/moderate PTSD, 60-79=Severe PTSD, 80=Extreme PTSD)
PTSD Checklist - Military Version (PCL-5) Total Score
时间窗: Week 12
PCL-5 will be used to collect information on PTSD symptoms. The PCL-5 is a 20-item self-report measure, selected for its dimensional sensitivity, with higher scores reflecting greater PTSD severity. Scoring is based on how much the patient has been bothered by the symptoms on a scale from "0 = not at all" to "4 = extremely." Items are summed to provide a total severity score (range 0-80). PCL-5 score between 31-33 is indicative of PTSD.
次要结局
未报告次要终点