Trial Outcomes & Findings for Treatment for Alcoholism and Post-Traumatic Stress Disorder (Naltrexone) (NCT NCT00006489)

Last Updated: 2017-04-21

Results Overview

The PSS-I-IV is a clinician-rated interview that evaluates PTSD symptoms on a frequency/severity scale corresponding to the DSM-IV symptom criteria. The measure has a total score range from 0 to 51, with higher scores indicating more severe PTSD symptoms.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

165 participants

Primary outcome timeframe

Week 0 (Pretreatment), Week 24 (Posttreatment), Week 52 (Follow-up)

Results posted on

2017-04-21

Participant Flow

Participant milestones

Participant milestones
Measure	Naltrexone + Supportive Counseling Naltrexone alone Naltrexone: Daily dosing 100 mg for 24 weeks	Naltrexone + CBT (Prolonged Exposure Therapy) Naltrexone with CBT for PTSD Cognitive-Behavioral Therapy: Twelve weekly 90-minute individual therapy sessions followed by (6) 90-minute sessions every other week Naltrexone: Daily dosing 100 mg for 24 weeks	Placebo + CBT (Prolonged Exposure Therapy) Placebo with CBT for PTSD Cognitive-Behavioral Therapy: Twelve weekly 90-minute individual therapy sessions followed by (6) 90-minute sessions every other week	Placebo + Supportive Counseling Placebo alone Placebo: Pill Placebo daily dosing 24 weeks
Overall Study STARTED	42	40	40	43
Overall Study COMPLETED	29	26	25	32
Overall Study NOT COMPLETED	13	14	15	11

Reasons for withdrawal

Reasons for withdrawal
Measure	Naltrexone + Supportive Counseling Naltrexone alone Naltrexone: Daily dosing 100 mg for 24 weeks	Naltrexone + CBT (Prolonged Exposure Therapy) Naltrexone with CBT for PTSD Cognitive-Behavioral Therapy: Twelve weekly 90-minute individual therapy sessions followed by (6) 90-minute sessions every other week Naltrexone: Daily dosing 100 mg for 24 weeks	Placebo + CBT (Prolonged Exposure Therapy) Placebo with CBT for PTSD Cognitive-Behavioral Therapy: Twelve weekly 90-minute individual therapy sessions followed by (6) 90-minute sessions every other week	Placebo + Supportive Counseling Placebo alone Placebo: Pill Placebo daily dosing 24 weeks
Overall Study Adverse Event	3	2	4	3
Overall Study Withdrawal by Subject	10	9	9	6
Overall Study Scheduling Conflict	0	3	2	1
Overall Study Death	0	0	0	1

Baseline Characteristics

Treatment for Alcoholism and Post-Traumatic Stress Disorder (Naltrexone)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Naltrexone + Supportive Counseling n=42 Participants Naltrexone alone Naltrexone: Daily dosing 100 mg for 24 weeks	Naltrexone + CBT (Prolonged Exposure Therapy) n=40 Participants Naltrexone with CBT for PTSD Cognitive-Behavioral Therapy: Twelve weekly 90-minute individual therapy sessions followed by (6) 90-minute sessions every other week Naltrexone: Daily dosing 100 mg for 24 weeks	Placebo + CBT (Prolonged Exposure Therapy) n=40 Participants Placebo with CBT for PTSD Cognitive-Behavioral Therapy: Twelve weekly 90-minute individual therapy sessions followed by (6) 90-minute sessions every other week	Placebo + Supportive Counseling n=43 Participants Placebo alone Placebo: Pill Placebo daily dosing 24 weeks	Total n=165 Participants Total of all reporting groups
Age, Continuous	44.9 years n=5 Participants	40.1 years n=7 Participants	44.7 years n=5 Participants	41.2 years n=4 Participants	42.7 years n=21 Participants
Sex: Female, Male Female	16 Participants n=5 Participants	13 Participants n=7 Participants	13 Participants n=5 Participants	15 Participants n=4 Participants	57 Participants n=21 Participants
Sex: Female, Male Male	26 Participants n=5 Participants	27 Participants n=7 Participants	27 Participants n=5 Participants	28 Participants n=4 Participants	108 Participants n=21 Participants
Race/Ethnicity, Customized Black	21 Participants n=5 Participants	30 Participants n=7 Participants	28 Participants n=5 Participants	26 Participants n=4 Participants	105 Participants n=21 Participants
Race/Ethnicity, Customized White	19 Participants n=5 Participants	9 Participants n=7 Participants	8 Participants n=5 Participants	14 Participants n=4 Participants	50 Participants n=21 Participants
Race/Ethnicity, Customized Hispanic	2 Participants n=5 Participants	1 Participants n=7 Participants	3 Participants n=5 Participants	1 Participants n=4 Participants	7 Participants n=21 Participants
Race/Ethnicity, Customized Native American	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants	1 Participants n=21 Participants
Race/Ethnicity, Customized Other	0 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	1 Participants n=4 Participants	2 Participants n=21 Participants
Region of Enrollment United States	42 Participants n=5 Participants	40 Participants n=7 Participants	40 Participants n=5 Participants	43 Participants n=4 Participants	165 Participants n=21 Participants
Types of trauma Sexual Assault	11 Participants n=5 Participants	12 Participants n=7 Participants	11 Participants n=5 Participants	8 Participants n=4 Participants	42 Participants n=21 Participants
Types of trauma Physical Assault	18 Participants n=5 Participants	16 Participants n=7 Participants	12 Participants n=5 Participants	16 Participants n=4 Participants	62 Participants n=21 Participants
Types of trauma Combat	4 Participants n=5 Participants	4 Participants n=7 Participants	7 Participants n=5 Participants	4 Participants n=4 Participants	19 Participants n=21 Participants
Types of trauma Other	9 Participants n=5 Participants	8 Participants n=7 Participants	10 Participants n=5 Participants	15 Participants n=4 Participants	42 Participants n=21 Participants

PRIMARY outcome

Timeframe: Week 0 (Pretreatment), Week 24 (Posttreatment), Week 52 (Follow-up)

Outcome measures

Outcome measures
Measure	Naltrexone + Supportive Counseling n=42 Participants Naltrexone alone Naltrexone: Daily dosing 100 mg for 24 weeks	Naltrexone + CBT (Prolonged Exposure Therapy) n=40 Participants Naltrexone with CBT for PTSD Cognitive-Behavioral Therapy: Twelve weekly 90-minute individual therapy sessions followed by (6) 90-minute sessions every other week Naltrexone: Daily dosing 100 mg for 24 weeks	Placebo + CBT (Prolonged Exposure Therapy) n=40 Participants Placebo with CBT for PTSD Cognitive-Behavioral Therapy: Twelve weekly 90-minute individual therapy sessions followed by (6) 90-minute sessions every other week	Placebo + Supportive Counseling n=43 Participants Placebo alone Placebo: Pill Placebo daily dosing 24 weeks
Posttraumatic Stress Disorder (PTSD) Symptom Scale - Interview (PSS-I-IV) Posttreatmwent (Week 24)	15.3 units on a scale Interval 12.2 to 18.3	12.2 units on a scale Interval 8.2 to 16.1	13.3 units on a scale Interval 9.3 to 17.3	15.5 units on a scale Interval 12.4 to 18.6
Posttraumatic Stress Disorder (PTSD) Symptom Scale - Interview (PSS-I-IV) Follow-up (Week 52)	10.9 units on a scale Interval 7.2 to 14.6	7.9 units on a scale Interval 4.1 to 11.8	10.8 units on a scale Interval 6.3 to 15.2	11.1 units on a scale Interval 8.2 to 14.1
Posttraumatic Stress Disorder (PTSD) Symptom Scale - Interview (PSS-I-IV) Pretreatment (Week 0)	27.1 units on a scale Interval 24.7 to 30.8	30.3 units on a scale Interval 27.7 to 32.9	27.7 units on a scale Interval 24.7 to 30.8	27.5 units on a scale Interval 25.4 to 29.6

PRIMARY outcome

Timeframe: Week 0 (Pretreatment), Week 24 (Posttreatment), Week 52 (Follow-up)

The TFBI is an interview that utilizes a calendar method to assess when and how much alcohol was consumed by the participant. At Week 0 (Pretreatment), Week 24 (Posttreatment), and Week 52 (Follow-up), alcohol consumed in the past 90 days was assessed. This measure was then used to calculate the percentage of days drinking in the past 90 days at each time point. Higher scores for percentage of days drinking indicate worse drinking outcomes.

Outcome measures

Outcome measures
Measure	Naltrexone + Supportive Counseling n=42 Participants Naltrexone alone Naltrexone: Daily dosing 100 mg for 24 weeks	Naltrexone + CBT (Prolonged Exposure Therapy) n=40 Participants Naltrexone with CBT for PTSD Cognitive-Behavioral Therapy: Twelve weekly 90-minute individual therapy sessions followed by (6) 90-minute sessions every other week Naltrexone: Daily dosing 100 mg for 24 weeks	Placebo + CBT (Prolonged Exposure Therapy) n=40 Participants Placebo with CBT for PTSD Cognitive-Behavioral Therapy: Twelve weekly 90-minute individual therapy sessions followed by (6) 90-minute sessions every other week	Placebo + Supportive Counseling n=43 Participants Placebo alone Placebo: Pill Placebo daily dosing 24 weeks
Drinking Timeline Follow-back Interview (TFBI) Pretreatment (Week 0)	75.4 percentage of days Interval 67.1 to 83.5	71.2 percentage of days Interval 62.5 to 79.9	78.6 percentage of days Interval 71.4 to 85.6	74.1 percentage of days Interval 66.4 to 81.8
Drinking Timeline Follow-back Interview (TFBI) Posttreatmwent (Week 24)	3.5 percentage of days Interval 0.1 to 6.8	7.3 percentage of days Interval 1.9 to 12.7	13.4 percentage of days Interval 5.5 to 21.1	13.2 percentage of days Interval 7.3 to 19.2
Drinking Timeline Follow-back Interview (TFBI) Follow-up (Week 52)	21.5 percentage of days Interval 10.6 to 32.4	8.8 percentage of days Interval 3.3 to 14.3	18.9 percentage of days Interval 8.8 to 29.1	27.3 percentage of days Interval 14.7 to 40.0

SECONDARY outcome

Timeframe: Week 0 (Pretreatment), Week 24 (Posttreatment), Week 52 (Follow-up)

The Penn Alcohol Craving Scale is a 5-item self-report measure. It assesses alcohol craving during the prior week. Total scores on this measure range from 0 to 30, with higher scores indicating a higher level of craving.

Outcome measures

Outcome measures
Measure	Naltrexone + Supportive Counseling n=42 Participants Naltrexone alone Naltrexone: Daily dosing 100 mg for 24 weeks	Naltrexone + CBT (Prolonged Exposure Therapy) n=40 Participants Naltrexone with CBT for PTSD Cognitive-Behavioral Therapy: Twelve weekly 90-minute individual therapy sessions followed by (6) 90-minute sessions every other week Naltrexone: Daily dosing 100 mg for 24 weeks	Placebo + CBT (Prolonged Exposure Therapy) n=40 Participants Placebo with CBT for PTSD Cognitive-Behavioral Therapy: Twelve weekly 90-minute individual therapy sessions followed by (6) 90-minute sessions every other week	Placebo + Supportive Counseling n=43 Participants Placebo alone Placebo: Pill Placebo daily dosing 24 weeks
Penn Alcohol Cravings Scale Pretreatment (Week 0)	17.7 percentage of days Interval 15.3 to 20.0	17.9 percentage of days Interval 15.8 to 20.1	19.2 percentage of days Interval 16.3 to 22.1	18.7 percentage of days Interval 16.7 to 20.7
Penn Alcohol Cravings Scale Posttreatmwent (Week 24)	8.0 percentage of days Interval 6.0 to 10.0	5.1 percentage of days Interval 3.4 to 6.7	9.1 percentage of days Interval 6.1 to 12.2	10.3 percentage of days Interval 8.2 to 12.4
Penn Alcohol Cravings Scale Follow-up (Week 52)	7.4 percentage of days Interval 4.2 to 10.6	6.0 percentage of days Interval 4.0 to 8.1	6.9 percentage of days Interval 4.2 to 9.7	8.9 percentage of days Interval 6.4 to 11.4

Adverse Events

Naltrexone + Supportive Counseling

Serious events: 3 serious events

Other events: 21 other events

Deaths: 0 deaths

Naltrexone + CBT (Prolonged Exposure Therapy)

Serious events: 2 serious events

Other events: 21 other events

Deaths: 0 deaths

Placebo + CBT (Prolonged Exposure Therapy)

Serious events: 4 serious events

Other events: 22 other events

Deaths: 0 deaths

Placebo + Supportive Counseling

Serious events: 3 serious events

Other events: 18 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Naltrexone + Supportive Counseling n=42 participants at risk Naltrexone alone Naltrexone: Daily dosing 100 mg for 24 weeks	Naltrexone + CBT (Prolonged Exposure Therapy) n=40 participants at risk Naltrexone with CBT for PTSD Cognitive-Behavioral Therapy: Twelve weekly 90-minute individual therapy sessions followed by (6) 90-minute sessions every other week Naltrexone: Daily dosing 100 mg for 24 weeks	Placebo + CBT (Prolonged Exposure Therapy) n=40 participants at risk Placebo with CBT for PTSD Cognitive-Behavioral Therapy: Twelve weekly 90-minute individual therapy sessions followed by (6) 90-minute sessions every other week	Placebo + Supportive Counseling n=43 participants at risk Placebo alone Placebo: Pill Placebo daily dosing 24 weeks
Psychiatric disorders Serious Suicidal Ideation	7.1% 3/42 • Adverse event data were collected throughout time of participant enrollment and involvement in the study. Participant enrollment began on February 8, 2001 and ended on June 25, 2009. Data collection was completed on August 12, 2010. Therefore, adverse event data were collected for 9 years, 6 months. Please Note: None of the Serious Adverse events were determined to be related to the study.	2.5% 1/40 • Adverse event data were collected throughout time of participant enrollment and involvement in the study. Participant enrollment began on February 8, 2001 and ended on June 25, 2009. Data collection was completed on August 12, 2010. Therefore, adverse event data were collected for 9 years, 6 months. Please Note: None of the Serious Adverse events were determined to be related to the study.	5.0% 2/40 • Adverse event data were collected throughout time of participant enrollment and involvement in the study. Participant enrollment began on February 8, 2001 and ended on June 25, 2009. Data collection was completed on August 12, 2010. Therefore, adverse event data were collected for 9 years, 6 months. Please Note: None of the Serious Adverse events were determined to be related to the study.	2.3% 1/43 • Adverse event data were collected throughout time of participant enrollment and involvement in the study. Participant enrollment began on February 8, 2001 and ended on June 25, 2009. Data collection was completed on August 12, 2010. Therefore, adverse event data were collected for 9 years, 6 months. Please Note: None of the Serious Adverse events were determined to be related to the study.
General disorders Serious Medical Illness	0.00% 0/42 • Adverse event data were collected throughout time of participant enrollment and involvement in the study. Participant enrollment began on February 8, 2001 and ended on June 25, 2009. Data collection was completed on August 12, 2010. Therefore, adverse event data were collected for 9 years, 6 months. Please Note: None of the Serious Adverse events were determined to be related to the study.	2.5% 1/40 • Adverse event data were collected throughout time of participant enrollment and involvement in the study. Participant enrollment began on February 8, 2001 and ended on June 25, 2009. Data collection was completed on August 12, 2010. Therefore, adverse event data were collected for 9 years, 6 months. Please Note: None of the Serious Adverse events were determined to be related to the study.	2.5% 1/40 • Adverse event data were collected throughout time of participant enrollment and involvement in the study. Participant enrollment began on February 8, 2001 and ended on June 25, 2009. Data collection was completed on August 12, 2010. Therefore, adverse event data were collected for 9 years, 6 months. Please Note: None of the Serious Adverse events were determined to be related to the study.	2.3% 1/43 • Adverse event data were collected throughout time of participant enrollment and involvement in the study. Participant enrollment began on February 8, 2001 and ended on June 25, 2009. Data collection was completed on August 12, 2010. Therefore, adverse event data were collected for 9 years, 6 months. Please Note: None of the Serious Adverse events were determined to be related to the study.
Psychiatric disorders Psychotic Symptoms	0.00% 0/42 • Adverse event data were collected throughout time of participant enrollment and involvement in the study. Participant enrollment began on February 8, 2001 and ended on June 25, 2009. Data collection was completed on August 12, 2010. Therefore, adverse event data were collected for 9 years, 6 months. Please Note: None of the Serious Adverse events were determined to be related to the study.	0.00% 0/40 • Adverse event data were collected throughout time of participant enrollment and involvement in the study. Participant enrollment began on February 8, 2001 and ended on June 25, 2009. Data collection was completed on August 12, 2010. Therefore, adverse event data were collected for 9 years, 6 months. Please Note: None of the Serious Adverse events were determined to be related to the study.	2.5% 1/40 • Adverse event data were collected throughout time of participant enrollment and involvement in the study. Participant enrollment began on February 8, 2001 and ended on June 25, 2009. Data collection was completed on August 12, 2010. Therefore, adverse event data were collected for 9 years, 6 months. Please Note: None of the Serious Adverse events were determined to be related to the study.	0.00% 0/43 • Adverse event data were collected throughout time of participant enrollment and involvement in the study. Participant enrollment began on February 8, 2001 and ended on June 25, 2009. Data collection was completed on August 12, 2010. Therefore, adverse event data were collected for 9 years, 6 months. Please Note: None of the Serious Adverse events were determined to be related to the study.
General disorders Death	0.00% 0/42 • Adverse event data were collected throughout time of participant enrollment and involvement in the study. Participant enrollment began on February 8, 2001 and ended on June 25, 2009. Data collection was completed on August 12, 2010. Therefore, adverse event data were collected for 9 years, 6 months. Please Note: None of the Serious Adverse events were determined to be related to the study.	0.00% 0/40 • Adverse event data were collected throughout time of participant enrollment and involvement in the study. Participant enrollment began on February 8, 2001 and ended on June 25, 2009. Data collection was completed on August 12, 2010. Therefore, adverse event data were collected for 9 years, 6 months. Please Note: None of the Serious Adverse events were determined to be related to the study.	0.00% 0/40 • Adverse event data were collected throughout time of participant enrollment and involvement in the study. Participant enrollment began on February 8, 2001 and ended on June 25, 2009. Data collection was completed on August 12, 2010. Therefore, adverse event data were collected for 9 years, 6 months. Please Note: None of the Serious Adverse events were determined to be related to the study.	2.3% 1/43 • Adverse event data were collected throughout time of participant enrollment and involvement in the study. Participant enrollment began on February 8, 2001 and ended on June 25, 2009. Data collection was completed on August 12, 2010. Therefore, adverse event data were collected for 9 years, 6 months. Please Note: None of the Serious Adverse events were determined to be related to the study.

Other adverse events

Additional Information

Dr. Edna Foa

University of Pennsylvania

Phone: 215-746-3327

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place