Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| R01AA012428 | U.S. NIH Grant/Contract | View source | |
| NIH grant R01-AA-012428 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| National Institute on Alcohol Abuse and Alcoholism (NIAAA) | NIH |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This study will evaluate naltrexone and cognitive-behavioral therapy treatments for alcohol dependence and post-traumatic stress disorder (PTSD). Subjects will be randomly assigned a 6-month treatment of either: 1) naltrexone alone, 2) naltrexone with PTSD psychosocial therapy, 3) a placebo with PTSD psychosocial therapy, or 4) placebo alone. An enhanced medication management intervention will accompany all treatment conditions. Follow-up assessments will be completed at 9 and 12 months after treatment.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Naltrexone alone | Active Comparator | Naltrexone alone |
|
| Naltrexone with CBT for PTSD | Active Comparator | Naltrexone with CBT for PTSD |
|
| Placebo with CBT for PTSD | Active Comparator | Placebo with CBT for PTSD |
|
| Placebo alone | Placebo Comparator | Placebo alone |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cognitive-Behavioral Therapy | Behavioral | Twelve weekly 90-minute individual therapy sessions followed by (6) 90-minute sessions every other week |
|
| Measure | Description | Time Frame |
|---|---|---|
| Posttraumatic Stress Disorder (PTSD) Symptom Scale - Interview (PSS-I-IV) | 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. | Week 0 (Pretreatment), Week 24 (Posttreatment), Week 52 (Follow-up) |
| Drinking Timeline Follow-back Interview (TFBI) | 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. | Week 0 (Pretreatment), Week 24 (Posttreatment), Week 52 (Follow-up) |
| Measure | Description | Time Frame |
|---|---|---|
| Penn Alcohol Cravings Scale | 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. | Week 0 (Pretreatment), Week 24 (Posttreatment), Week 52 (Follow-up) |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Edna B. Foa, PhD | University of Pennsylvania | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Center for Anxiety, University of Pennsylvania | Philadelphia | Pennsylvania | 19104 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27930926 | Derived | Zang Y, Yu J, Chazin D, Asnaani A, Zandberg LJ, Foa EB. Changes in coping behavior in a randomized controlled trial of concurrent treatment for PTSD and alcohol dependence. Behav Res Ther. 2017 Mar;90:9-15. doi: 10.1016/j.brat.2016.11.013. Epub 2016 Nov 24. | |
| 26905901 | Derived | Kaczkurkin AN, Asnaani A, Alpert E, Foa EB. The impact of treatment condition and the lagged effects of PTSD symptom severity and alcohol use on changes in alcohol craving. Behav Res Ther. 2016 Apr;79:7-14. doi: 10.1016/j.brat.2016.02.001. Epub 2016 Feb 15. |
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Naltrexone + Supportive Counseling | Naltrexone alone Naltrexone: Daily dosing 100 mg for 24 weeks |
| FG001 | 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 |
| FG002 | 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 |
| FG003 | Placebo + Supportive Counseling | Placebo alone Placebo: Pill Placebo daily dosing 24 weeks |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Naltrexone + Supportive Counseling | Naltrexone alone Naltrexone: Daily dosing 100 mg for 24 weeks |
| BG001 | 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 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Posttraumatic Stress Disorder (PTSD) Symptom Scale - Interview (PSS-I-IV) | 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. | Posted | Mean | 95% Confidence Interval | units on a scale | Week 0 (Pretreatment), Week 24 (Posttreatment), Week 52 (Follow-up) |
|
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.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Naltrexone + Supportive Counseling | Naltrexone alone Naltrexone: Daily dosing 100 mg for 24 weeks |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Serious Suicidal Ideation | Psychiatric disorders | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Back Pain | General disorders | Systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Edna Foa | University of Pennsylvania | 215-746-3327 | foa@mail.med.upenn.edu |
Not provided
| ID | Term |
|---|---|
| D000437 | Alcoholism |
| D013313 | Stress Disorders, Post-Traumatic |
| ID | Term |
|---|---|
| D019973 | Alcohol-Related Disorders |
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
Not provided
Not provided
| ID | Term |
|---|---|
| D015928 | Cognitive Behavioral Therapy |
| D009271 | Naltrexone |
| ID | Term |
|---|---|
| D001521 | Behavior Therapy |
| D011613 | Psychotherapy |
| D004191 | Behavioral Disciplines and Activities |
| D009270 | Naloxone |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Naltrexone | Drug | Daily dosing 100 mg for 24 weeks |
|
| Placebo | Drug | Pill Placebo daily dosing 24 weeks |
|
| 23925619 | Derived | Foa EB, Yusko DA, McLean CP, Suvak MK, Bux DA Jr, Oslin D, O'Brien CP, Imms P, Riggs DS, Volpicelli J. Concurrent naltrexone and prolonged exposure therapy for patients with comorbid alcohol dependence and PTSD: a randomized clinical trial. JAMA. 2013 Aug 7;310(5):488-95. doi: 10.1001/jama.2013.8268. |
| 22480715 | Derived | Powers MB, Gillihan SJ, Rosenfield D, Jerud AB, Foa EB. Reliability and validity of the PDS and PSS-I among participants with PTSD and alcohol dependence. J Anxiety Disord. 2012 Jun;26(5):617-23. doi: 10.1016/j.janxdis.2012.02.013. Epub 2012 Mar 3. |
| Withdrawal by Subject |
|
| Scheduling Conflict |
|
| Death |
|
| BG002 | 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 |
| BG003 | Placebo + Supportive Counseling | Placebo alone Placebo: Pill Placebo daily dosing 24 weeks |
| BG004 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| Types of trauma | Count of Participants | Participants |
|
| OG002 | 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 |
| OG003 | Placebo + Supportive Counseling | Placebo alone Placebo: Pill Placebo daily dosing 24 weeks |
|
|
| Primary | Drinking Timeline Follow-back Interview (TFBI) | 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. | Posted | Mean | 95% Confidence Interval | percentage of days | Week 0 (Pretreatment), Week 24 (Posttreatment), Week 52 (Follow-up) |
|
|
|
| Secondary | Penn Alcohol Cravings Scale | 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. | Posted | Mean | 95% Confidence Interval | percentage of days | Week 0 (Pretreatment), Week 24 (Posttreatment), Week 52 (Follow-up) |
|
|
|
| 3 |
| 42 |
| 21 |
| 42 |
| EG001 | 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 | 2 | 40 | 21 | 40 |
| EG002 | 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 | 4 | 40 | 22 | 40 |
| EG003 | Placebo + Supportive Counseling | Placebo alone Placebo: Pill Placebo daily dosing 24 weeks | 3 | 43 | 18 | 43 |
| Serious Medical Illness | General disorders | Systematic Assessment |
|
| Psychotic Symptoms | Psychiatric disorders | Systematic Assessment |
|
| Death | General disorders | Systematic Assessment |
|
| Diarrhea | Renal and urinary disorders | Systematic Assessment |
|
| Gastrointestinal Issues | Gastrointestinal disorders | Systematic Assessment |
|
| Changes to Vision | Eye disorders | Systematic Assessment |
|
| Toothache | General disorders | Systematic Assessment |
|
| Anxiety | General disorders | Systematic Assessment |
|
| Headache | General disorders | Systematic Assessment |
|
| Loose Stool | Gastrointestinal disorders | Systematic Assessment |
|
| Sedation | General disorders | Systematic Assessment |
|
| Stomach Pain | Gastrointestinal disorders | Systematic Assessment |
|
| Muscle Aches | General disorders | Systematic Assessment |
|
| Cold | Immune system disorders | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | Systematic Assessment |
|
| Dry Mouth | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Increased Bowel Movements | Gastrointestinal disorders | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | Systematic Assessment |
|
| Stomach Virus | Infections and infestations | Systematic Assessment |
|
| Increased Irritability | General disorders | Systematic Assessment |
|
| Fatigue | General disorders | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | Systematic Assessment |
|
| Dizziness | General disorders | Systematic Assessment |
|
Not provided
Not provided
| D040921 | Stress Disorders, Traumatic |
| D000068099 | Trauma and Stressor Related Disorders |
| D009019 |
| Morphinans |
| D053610 | Opiate Alkaloids |
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
| D006572 | Heterocyclic Compounds, Bridged-Ring |
| D006576 | Heterocyclic Compounds, 4 or More Rings |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D010616 | Phenanthrenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D011083 | Polycyclic Compounds |
| Posttreatmwent (Week 24) |
|
| Follow-up (Week 52) |
|
| Posttreatmwent (Week 24) |
|
| Follow-up (Week 52) |
|