Trial Outcomes & Findings for Optimal Treatment of Veterans With PTSD and Comorbid OUD (NCT NCT03605342)

Last Updated: 2024-08-19

Results Overview

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)

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

38 participants

Primary outcome timeframe

Baseline

Results posted on

2024-08-19

Participant Flow

Participant milestones

Participant milestones
Measure	Buprenorphine + CPT-C Buprenorphine (BUP) induction and stabilization for all participants (x1 week). Participants will be started at a dose of 2mg/0.5 mg buprenorphine and naloxone (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. Buprenorphine: 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, which is standard practice. Cognitive Processing Therapy (CPT): CPT-C is a manualized, 12-session 1:1 cognitive therapy that has been designed for patients with PTSD. In this study the sessions will be conducted weekly. CPT-C uses Socratic questioning targeting distorted cognitions such as self-blame, hindsight bias, and other guilt cognitions. CPT-C is focused on the cognitive components of the therapy without exposure.	Buprenorphine + IDC Buprenorphine (BUP) induction and stabilization for all participants (x1 week). Participants will be started at a dose of 2mg/0.5 mg buprenorphine and naloxone (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 Buprenorphine: 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, which is standard practice. Individual Drug Counseling (IDC): IDC will serve as the control group. The current standard of treatment for Veterans entering buprenorphine maintenance is to do drug counseling. Standard counseling is the primary means to achieve goals. IDC uses a semi-structured, time-limited addictions-counseling model in a 1:1 setting. The IDC manual provides an organized, concise version of what is currently practiced by most addiction counselors.
Overall Study STARTED	20	18
Overall Study COMPLETED	10	10
Overall Study NOT COMPLETED	10	8

Reasons for withdrawal

Reasons for withdrawal
Measure	Buprenorphine + CPT-C Buprenorphine (BUP) induction and stabilization for all participants (x1 week). Participants will be started at a dose of 2mg/0.5 mg buprenorphine and naloxone (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. Buprenorphine: 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, which is standard practice. Cognitive Processing Therapy (CPT): CPT-C is a manualized, 12-session 1:1 cognitive therapy that has been designed for patients with PTSD. In this study the sessions will be conducted weekly. CPT-C uses Socratic questioning targeting distorted cognitions such as self-blame, hindsight bias, and other guilt cognitions. CPT-C is focused on the cognitive components of the therapy without exposure.	Buprenorphine + IDC Buprenorphine (BUP) induction and stabilization for all participants (x1 week). Participants will be started at a dose of 2mg/0.5 mg buprenorphine and naloxone (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 Buprenorphine: 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, which is standard practice. Individual Drug Counseling (IDC): IDC will serve as the control group. The current standard of treatment for Veterans entering buprenorphine maintenance is to do drug counseling. Standard counseling is the primary means to achieve goals. IDC uses a semi-structured, time-limited addictions-counseling model in a 1:1 setting. The IDC manual provides an organized, concise version of what is currently practiced by most addiction counselors.
Overall Study Withdrawal by Subject	9	7
Overall Study Lost to Follow-up	1	1

Baseline Characteristics

Optimal Treatment of Veterans With PTSD and Comorbid OUD

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Buprenorphine + CPT-C n=20 Participants 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. Buprenorphine: 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, which is standard practice. Cognitive Processing Therapy (CPT): CPT-C is a manualized, 12-session 1:1 cognitive therapy that has been designed for patients with PTSD. In this study the sessions will be conducted weekly. CPT-C uses Socratic questioning targeting distorted cognitions such as self-blame, hindsight bias, and other guilt cognitions. CPT-C is focused on the cognitive components of the therapy without exposure.	Buprenorphine + IDC n=18 Participants 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 Buprenorphine: 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, which is standard practice. Individual Drug Counseling (IDC): IDC will serve as the control group. The current standard of treatment for Veterans entering buprenorphine maintenance is to do drug counseling. Standard counseling is the primary means to achieve goals. IDC uses a semi-structured, time-limited addictions-counseling model in a 1:1 setting. The IDC manual provides an organized, concise version of what is currently practiced by most addiction counselors.	Total n=38 Participants Total of all reporting groups
Age, Continuous	45.5 years STANDARD_DEVIATION 12.74 • n=5 Participants	48.44 years STANDARD_DEVIATION 11 • n=7 Participants	46.89 years STANDARD_DEVIATION 11.89 • n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants	3 Participants n=7 Participants	3 Participants n=5 Participants
Sex: Female, Male Male	20 Participants n=5 Participants	15 Participants n=7 Participants	35 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	3 Participants n=5 Participants	5 Participants n=7 Participants	8 Participants n=5 Participants
Race (NIH/OMB) White	15 Participants n=5 Participants	13 Participants n=7 Participants	28 Participants n=5 Participants
Race (NIH/OMB) More than one race	2 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	20 Participants n=5 Participants	18 Participants n=7 Participants	38 Participants n=5 Participants
Trauma Types Combat Exposure	10 Participants n=5 Participants	6 Participants n=7 Participants	16 Participants n=5 Participants
Trauma Types Sexual Assault	5 Participants n=5 Participants	5 Participants n=7 Participants	10 Participants n=5 Participants
Trauma Types Serious Accident/Assault	3 Participants n=5 Participants	4 Participants n=7 Participants	7 Participants n=5 Participants
Trauma Types Witnessing Severe Injury or Death	2 Participants n=5 Participants	3 Participants n=7 Participants	5 Participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline

Outcome measures

Outcome measures
Measure	Buprenorphine + CPT-C n=20 Participants 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. Buprenorphine: 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, which is standard practice. Cognitive Processing Therapy (CPT): CPT-C is a manualized, 12-session 1:1 cognitive therapy that has been designed for patients with PTSD. In this study the sessions will be conducted weekly. CPT-C uses Socratic questioning targeting distorted cognitions such as self-blame, hindsight bias, and other guilt cognitions. CPT-C is focused on the cognitive components of the therapy without exposure.	Buprenorphine + IDC n=18 Participants 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 Buprenorphine: 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, which is standard practice. Individual Drug Counseling (IDC): IDC will serve as the control group. The current standard of treatment for Veterans entering buprenorphine maintenance is to do drug counseling. Standard counseling is the primary means to achieve goals. IDC uses a semi-structured, time-limited addictions-counseling model in a 1:1 setting. The IDC manual provides an organized, concise version of what is currently practiced by most addiction counselors.
Clinician Administered PTSD Scale (CAPS-5)	31.95 units on a scale Standard Error 2.62	34.38 units on a scale Standard Error 2.76

PRIMARY outcome

Timeframe: Baseline

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.

Outcome measures

Outcome measures
Measure	Buprenorphine + CPT-C n=20 Participants 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. Buprenorphine: 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, which is standard practice. Cognitive Processing Therapy (CPT): CPT-C is a manualized, 12-session 1:1 cognitive therapy that has been designed for patients with PTSD. In this study the sessions will be conducted weekly. CPT-C uses Socratic questioning targeting distorted cognitions such as self-blame, hindsight bias, and other guilt cognitions. CPT-C is focused on the cognitive components of the therapy without exposure.	Buprenorphine + IDC n=18 Participants 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 Buprenorphine: 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, which is standard practice. Individual Drug Counseling (IDC): IDC will serve as the control group. The current standard of treatment for Veterans entering buprenorphine maintenance is to do drug counseling. Standard counseling is the primary means to achieve goals. IDC uses a semi-structured, time-limited addictions-counseling model in a 1:1 setting. The IDC manual provides an organized, concise version of what is currently practiced by most addiction counselors.
PTSD Checklist - Military Version (PCL-5) Total Score	44.80 units on a scale Standard Error 3.66	45.44 units on a scale Standard Error 3.86

PRIMARY outcome

Timeframe: Week 12

Outcome measures

Outcome measures
Measure	Buprenorphine + CPT-C n=20 Participants 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. Buprenorphine: 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, which is standard practice. Cognitive Processing Therapy (CPT): CPT-C is a manualized, 12-session 1:1 cognitive therapy that has been designed for patients with PTSD. In this study the sessions will be conducted weekly. CPT-C uses Socratic questioning targeting distorted cognitions such as self-blame, hindsight bias, and other guilt cognitions. CPT-C is focused on the cognitive components of the therapy without exposure.	Buprenorphine + IDC n=18 Participants 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 Buprenorphine: 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, which is standard practice. Individual Drug Counseling (IDC): IDC will serve as the control group. The current standard of treatment for Veterans entering buprenorphine maintenance is to do drug counseling. Standard counseling is the primary means to achieve goals. IDC uses a semi-structured, time-limited addictions-counseling model in a 1:1 setting. The IDC manual provides an organized, concise version of what is currently practiced by most addiction counselors.
Clinician Administered PTSD Scale (CAPS-5)	29.59 units on a scale Standard Error 3.64	27.12 units on a scale Standard Error 3.25

PRIMARY outcome

Timeframe: Week 12

Outcome measures

Outcome measures
Measure	Buprenorphine + CPT-C n=20 Participants 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. Buprenorphine: 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, which is standard practice. Cognitive Processing Therapy (CPT): CPT-C is a manualized, 12-session 1:1 cognitive therapy that has been designed for patients with PTSD. In this study the sessions will be conducted weekly. CPT-C uses Socratic questioning targeting distorted cognitions such as self-blame, hindsight bias, and other guilt cognitions. CPT-C is focused on the cognitive components of the therapy without exposure.	Buprenorphine + IDC n=18 Participants 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 Buprenorphine: 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, which is standard practice. Individual Drug Counseling (IDC): IDC will serve as the control group. The current standard of treatment for Veterans entering buprenorphine maintenance is to do drug counseling. Standard counseling is the primary means to achieve goals. IDC uses a semi-structured, time-limited addictions-counseling model in a 1:1 setting. The IDC manual provides an organized, concise version of what is currently practiced by most addiction counselors.
PTSD Checklist - Military Version (PCL-5) Total Score	34.17 units on a scale Standard Error 4.23	29.39 units on a scale Standard Error 4.30

Adverse Events

Buprenorphine + CPT-C

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Buprenorphine + IDC

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr Ismene Petrakis

VA Connecticut Healthcare System

Phone: 203-932-5711

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place