Study of the Medication Prazosin for Alcohol Dependence

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2013 by Seattle Institute for Biomedical and Clinical Research
Sponsor:
Collaborators:
VA Puget Sound Health Care System
University of Washington
Information provided by (Responsible Party):
Seattle Institute for Biomedical and Clinical Research
ClinicalTrials.gov Identifier:
NCT00762710
First received: September 26, 2008
Last updated: August 5, 2013
Last verified: August 2013
  Purpose

The purpose of this study is to determine whether the drug prazosin is effective for the treatment of alcohol dependency.


Condition Intervention Phase
Alcoholism
Drug: Prazosin medication
Drug: Placebo medication
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Clinical Trial of the Adrenergic Alpha-1 Antagonist Prazosin for Alcohol Dependence

Resource links provided by NLM:


Further study details as provided by Seattle Institute for Biomedical and Clinical Research:

Primary Outcome Measures:
  • Alcohol consumption and cravings [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 150
Study Start Date: January 2009
Estimated Study Completion Date: November 2013
Estimated Primary Completion Date: November 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Prazosin medication
Drug: Prazosin medication

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

Other Name: Minipress
Placebo Comparator: 2
Placebo medication
Drug: 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


Detailed Description:

Alcohol dependence (AD) afflicts nearly 10% of the US population and causes marked medical morbidity and mortality, marked psychiatric morbidity, increased health care costs, and lost work hours (Saxon, Malte, Sloan, et al., 2006; McFall, Saxon, Thaneemit-Chen, et al., 2007). Alcohol dependence is a biologically, genetically based disease, yet the majority of clinically accepted treatments are behaviorally or psychosocially based (Anton, O'Malley, Ciraulo, et al., 2006; Todd, Armeli, Tennen, et al., 2005). Despite the initial success of these treatments, 40-70% of patients relapse within the first 12 months after treatment (McGinnis & Foege, 1993). Research is needed to develop more effective biological treatments.

Currently, only three pharmacological treatments are FDA approved for the treatment of alcohol dependence and all are sub-optimal. None of these medications directly target noradrenergic brain systems. Recent advances in understanding the neurobiology of substance dependence and relapse support the notion that adrenergic systems play a critical role in these processes.

In a 6-week, double-blind, placebo-controlled pilot study, we randomized 24 participants without PTSD entering treatment for AD to prazosin or identical appearing placebo (Simpson et al., 2009). The prazosin group reported no more adverse events than the placebo group, and controlling for drinks per week at baseline and week number, the prazosin group reported fewer drinks per week in the final 3 weeks of the study. These findings led us to conduct a larger trial to further evaluate prazosin for AD.

The current study is a 16-week, randomized, two group parallel-design, double-blind, placebo-controlled trial to evaluate the efficacy of prazosin for decreasing alcohol use and the subjective experience of alcohol craving in individuals without PTSD who are seeking treatment for AD. Following randomization, a 2-week titration period will be followed by 10 weeks of stable dosing of prazosin or placebo. Study participants will attend study visits at least weekly for 12 weeks and will complete a final follow-up one month after discontinuation of the medication phase of the study at 16 weeks post-randomization. All study participants will also participate in Medical Management (MM) treatment, a behavioral intervention that has demonstrated efficacy as a behavioral platform for treatment of AD (Anton, O'Malley, Ciraulo, et al., 2006). Study participants will not be involved in other professional counseling or substance abuse treatment during their study involvement, though 12-step meeting attendance is encouraged during MM. Daily monitoring of alcohol craving, alcohol use, other substance craving and substance use, medication compliance, and key psychiatric symptoms via toll-free telephone calls to an Interactive Voice Response (IVR) system will continue throughout the 16-week study. Outcome measures will address alcohol use and craving and include IVR reports of craving and use, the TLFB for alcohol use, Penn Alcohol Craving Scale (PACS), Patient Health Questionnaire-9 (depression), urine toxicology analysis (UDA), and Breathalyzer readings.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Current primary DSM-IV diagnosis of alcohol dependence(AD)
  • 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 and literacy

Exclusion Criteria:

  • Psychiatric/behavioral: current post-traumatic stress disorder(PTSD); 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00762710

Contacts
Contact: Ian Pocock, B.A. 206-277-4872
Contact: Bergetta Dietel, B.A. 206-277-4015

Locations
United States, Washington
VA Puget Sound Health Care System Recruiting
Seattle, Washington, United States, 98108
Contact: Ian Pocock, B.A.    206-277-4872      
Contact: Bergetta M Dietel, B.A    206-277-4015      
Sponsors and Collaborators
Seattle Institute for Biomedical and Clinical Research
VA Puget Sound Health Care System
University of Washington
Investigators
Principal Investigator: Tracy L Simpson, Ph.D. VA Puget Sound Health Care System
  More Information

Publications:
Responsible Party: Seattle Institute for Biomedical and Clinical Research
ClinicalTrials.gov Identifier: NCT00762710     History of Changes
Other Study ID Numbers: 1 R01 AA 017184-01
Study First Received: September 26, 2008
Last Updated: August 5, 2013
Health Authority: United States: Federal Government
United States: Institutional Review Board

Keywords provided by Seattle Institute for Biomedical and Clinical Research:
Binge
Alcohol
Abuse
Use
Disorder
Dependence
Symptoms
Alcoholic
Alcoholism
Prazosin
Drug
Medicine
Medication
Treatment
Study
Placebo
Medical
Management
Craving
Consumption
Drinking
Drink
Heavy

Additional relevant MeSH terms:
Alcoholism
Alcohol-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Substance-Related Disorders
Adrenergic alpha-1 Receptor Antagonists
Prazosin
Adrenergic Agents
Adrenergic alpha-Antagonists
Adrenergic Antagonists
Antihypertensive Agents
Cardiovascular Agents
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on October 20, 2014