Posttraumatic Stress Disorder Clinical Trial
Official title:
A Placebo-Controlled Trial of Prazosin in Individuals With Co-occurring Alcohol Dependence and PTSD Seeking Abstinence
Verified date | August 2020 |
Source | Seattle Institute for Biomedical and Clinical Research |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The purpose of this study is to determine whether the drug prazosin is effective for the treatment of alcohol dependency and symptoms of Posttraumatic Stress Disorder (PTSD).
Status | Completed |
Enrollment | 30 |
Est. completion date | June 2012 |
Est. primary completion date | June 2012 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Current primary DSM-IV diagnosis of alcohol dependence(AD) - Current DSM-IV diagnosis of PTSD - At least 14 (women) or 21 (men) drinks per week AND at least 2 days of heavy drinking during a consecutive 30 day period in the last 90 days - Desire to abstain from drinking - At least 18 years of age - Good general medical health (see Exclusion Criteria below) - Capacity to provide informed consent - English fluency Exclusion Criteria: Psychiatric/behavioral: - psychiatric disorder requiring any medication other than anti-depressants (individuals not on a stable dose of an anti-depressant for at least 30 days prior to randomization will be excluded from the study) - currently taking disulfiram, acamprosate, or naltrexone in the last 30 days or planning to take any of these medications during the 12-week medication phase of the study - acutely suicidal or homicidal - current dependence on any other psychoactive substance other than nicotine or cannabis - a current diagnosis of opioid abuse, use of any opioid- containing medications, methamphetamines, or benzodiazepines during the previous month, or UDA positive for opioids, methamphetamines, benzodiazepines, or sedative hypnotics Medical: - significant acute or chronic medical illness including unstable angina, recent myocardial infarction, history of congestive heart failure, preexisting hypotension (systolic <110) or orthostatic hypotension (defined as a systolic drop > 20mmHg after two minutes standing or any drop with dizziness); insulin-dependent diabetes mellitus; chronic renal or hepatic failure, pancreatitis, Meniere's disease, benign positional vertigo, narcolepsy - for males only, concomitant use of trazodone (or use in the last 7 days), tadalafil, or vardenafil (or use in the last 3 days) due to increased risk of priapism - history of prazosin-sensitivity; no prazosin for at least the past 30 days - women who are pregnant, nursing infant(s), or of childbearing potential and not using a contraceptive method judged by the study physician or PA to be effective - signs or symptoms of alcohol withdrawal at the time of initial consent - legal involvement that could interfere with study treatment - individuals court ordered for treatment will not be eligible to participate in this study |
Country | Name | City | State |
---|---|---|---|
United States | VA Puget Sound Health Care System | Seattle | Washington |
Lead Sponsor | Collaborator |
---|---|
Seattle Institute for Biomedical and Clinical Research | National Institute on Alcohol Abuse and Alcoholism (NIAAA), VA Puget Sound Health Care System |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Percent Drinking Days Per Week | Data for this measure came from the Form-42 and daily IVR (Interactive Voice Response) monitoring. The percentage of drinking days of each participant was calculated by summing the number of drinking days and comparing them with the number of total drinking days in the same week. The percentage of drinking days from each week was added and averaged to get the percentage of drinking days per week per participant. The percentage of drinking days of all participants in the Prazosin group was added and averaged to get the mean of the percentage of weekly drinking days of the Prazosin group. These steps were repeated for the Placebo group. | 6 weeks | |
Primary | Percent Heavy Drinking Days Per Week | Data for this measure came from the Form-42 and daily IVR (Interactive Voice Response) monitoring. Heavy drinking was defined as 5 or more drinks per day for men and 4 or more drinks per day for women. The percentage of heavy drinking days of each participant was calculated by summing the number of heavy drinking days and comparing them with the total number of drinking days in the same week. The percentage of heavy drinking days from each week was added and averaged to get the percentage of heavy drinking days per week per participant. The percentage of heavy drinking days of all participants in the Prazosin group was added and averaged to get the mean of percentage of weekly heavy drinking days of the Prazosin group. These steps were repeated for the Placebo group. | 6 weeks | |
Primary | Total Drinks Per Week | Data for this measure came from the Form-42 and daily IVR (Interactive Voice Response) monitoring. The weekly total drinks of each participant were calculated by adding the number of drinks by week. The total drinks from each week were added and averaged to get the weekly total drinks of each participant. The weekly total drinks of all participants in the Prazosin group were added and averaged to get the total drinks per week for the Prazosin group. These steps were repeated for the Placebo group. | 6 weeks | |
Secondary | PTSD Symptom Assessments | PTSD symptoms/changes in PTSD (Post-Traumatic Stress Disorder) symptomatology was calculated using data from the IVR (interactive Voice Response) monitoring. PTSD scores were derived by computing the daily average of the item totals for overall PTSD and the symptom clusters. The rating range was 0 (not at all) to 8 (extremely). The higher the score/rating, the more severe the PTSD symptoms. The lowest and highest possible average are 0 and 8, respectively. | 6 weeks |
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