This trial is active, not recruiting.

Conditions alcohol abuse, posttraumatic stress disorder
Treatments prazosin, placebo medication
Phase phase 2
Sponsor Seattle Institute for Biomedical and Clinical Research
Collaborator National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Start date September 2009
End date August 2012
Trial size 90 participants
Trial identifier NCT01518972, P20 AA 017839


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).

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking double blind (subject, outcomes assessor)
Primary purpose treatment
Prazosin medication
prazosin Minipress
Form: Prazosin will be taken orally, in the form of pills. Dosing: 9 AM, 3 PM, 9 PM Days 1-2: 0 mg, 0 mg, 1 mg Days 3-4: 1 mg, 1 mg, 1 mg Days 5-7: 2 mg, 2 mg, 2 mg Day 8-10: 2 mg, 2 mg, 6 mg Day 11-14: 4 mg, 4 mg, 6 mg Day 15-84: 4 mg, 4 mg, 8 mg
(Placebo Comparator)
Placebo medication
placebo medication
Form: Placebo will be taken orally, in the form of pills. Dosing: 9 AM, 3 PM, 9 PM Days 1-2: 0 mg, 0 mg, 1 mg Days 3-4: 1 mg, 1 mg, 1 mg Days 5-7: 2 mg, 2 mg, 2 mg Day 8-10: 2 mg, 2 mg, 6 mg Day 11-14: 4 mg, 4 mg, 6 mg Day 15-84: 4 mg, 4 mg, 8 mg

Primary Outcomes

Alcohol consumption and cravings
time frame: 8 weeks
PTSD Symptoms
time frame: 8 weeks

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria: - Current primary DSM-IV diagnosis of alcohol dependence(AD) - Current DSM-IV diagnosis of PTSD - Heavy drinking in the last 30 days - 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 - currently taking disulfiram, acamprosate, or naltrexone or planning to take any of these medications during the 12-week medication phase of the study - current dependence on any other psychoactive substance other than nicotine or cannabis - a current diagnosis of opioid abuse, use of any opioid- containing medications or benzodiazepines during the previous month, or UDA positive for opioids, benzodiazepines, or sedative hypnotics Medical: - significant acute or chronic medical illness; 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

Additional Information

Official title A Placebo-Controlled Trial of Prazosin in Individuals With Co-occurring Alcohol Dependence and PTSD Seeking Abstinence
Principal investigator Tracy Simpson, PhD
Description Background: Alcohol dependence (AD) is a biologically, genetically based disease, yet the majority of clinically accepted treatments are behaviorally or psychosocially based. PTSD and alcohol use disorders (AUDs) commonly co-occur. This comorbidity is associated with more severe clinical impairment, shorter times to relapse, more treatment recidivism, overall greater use of treatment services, and greater treatment costs. Neuropharmacology of alcohol and prazosin: Emerging pre-clinical evidence shows that noradrenergic systems are involved in brain processes relevant to AD, such as arousal, reinforcement, and stress responsivity. However, virtually no work to date has attempted to translate this knowledge into clinically effective biological interventions. The investigators have adopted the novel, promising strategy of reducing adrenergic activity by blocking noradrenaline binding to post-synaptic alpha-1 receptors via the non-selective, alpha-1 antagonist, prazosin. Preclinical studies have demonstrated that prazosin decreases reinstatement of alcohol consumption, and preliminary clinical data suggest that prazosin reduces alcohol use in humans with AD and reduces PTSD-related nightmares and other symptoms, though it has not been tested in individuals with comorbid AD and PTSD. Prazosin, FDA approved to treat hypertension, typically has few side effects, and is inexpensive. Design: Randomized double-blind placebo-controlled clinical trial. Participants: 60 individuals with both AD and PTSD (25% women) with stated goal to abstain from alcohol use. Intervention: Either prazosin titrated per study protocol or matched placebo for 6 weeks with Medical Management (MM) based on the COMBINE Study procedures and a final study visit two weeks after medication discontinuation. Measures: The primary outcomes are alcohol use during the 12-week medication phase of the study and reports of craving during the same time period. Daily, prompted Interactive Voice Response (IVR) telephone monitoring will be done throughout the 8-week study to assess the primary outcomes and to provide information on affect and medication adherence. Such daily monitoring provides more accurate reports of alcohol use than standard retrospective outcome measures. Analyses: Hierarchical linear modeling to test for main effects of prazosin+MM versus placebo+MM on alcohol use and PTSD symptoms over time, and to evaluate whether reductions in PTSD mediate the effect of prazosin. Findings to date: The investigators have enrolled 30 participants and the 19 who met all the initial screening criteria were randomized overall. Since the last continuing review the investigators have enrolled 24 and randomized 15. Of the 24 participants enrolled, five are veterans and four of these has been randomized. Since the last continuing review, there have been two serious adverse events . In each case the institutional review board (IRB) review determined they were probably unrelated to the study. Enrollment continues. Public health implications: There is a paucity of safe, tolerable, inexpensive, and efficacious drugs currently available for the treatment of AD and PTSD. Should the investigators find that prazosin leads to reduced alcohol use and PTSD symptom severity relative to placebo, clinicians will have an additional tool to help people with PTSD who are dependent on alcohol to make crucial changes in their lives.
Trial information was received from ClinicalTrials.gov and was last updated in August 2012.
Information provided to ClinicalTrials.gov by Seattle Institute for Biomedical and Clinical Research.