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Study of the Medication Prazosin for Alcohol Dependence

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00762710
Recruitment Status : Completed
First Posted : September 30, 2008
Results First Posted : June 4, 2020
Last Update Posted : June 4, 2020
Sponsor:
Collaborators:
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
VA Puget Sound Health Care System
University of Washington
Information provided by (Responsible Party):
Seattle Institute for Biomedical and Clinical Research

Tracking Information
First Submitted Date  ICMJE September 26, 2008
First Posted Date  ICMJE September 30, 2008
Results First Submitted Date  ICMJE October 18, 2018
Results First Posted Date  ICMJE June 4, 2020
Last Update Posted Date June 4, 2020
Actual Study Start Date  ICMJE January 2008
Actual Primary Completion Date June 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 1, 2020)
Alcohol Consumption [ Time Frame: 12 weeks ]
At the baseline and final medication visits, the Form 90 (19) was used to assess alcohol and drug use for the preceding 90-day period
Original Primary Outcome Measures  ICMJE
 (submitted: September 26, 2008)
Alcohol consumption and cravings [ Time Frame: 16 weeks ]
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study of the Medication Prazosin for Alcohol Dependence
Official Title  ICMJE Clinical Trial of the Adrenergic Alpha-1 Antagonist Prazosin for Alcohol Dependence
Brief Summary The purpose of this study is to determine whether the drug prazosin is effective for the treatment of alcohol dependency.
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Alcoholism
Intervention  ICMJE
  • 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
  • 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

    Other Name: No other intervention names
Study Arms  ICMJE
  • Experimental: 1 - Prazosin Medication
    Following randomization, participants in this arm will receive a 2-week titration of Prazosin followed by 10 weeks of stable dosing of Prazosin. They will also 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.
    Intervention: Drug: Prazosin medication
  • Placebo Comparator: 2 - Placebo Medication
    Following randomization, participants in this arm will receive a 2-week titration of placebo followed by 10 weeks of stable dosing of placebo. They will also 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.
    Intervention: Drug: Placebo medication
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: June 1, 2020)
92
Original Estimated Enrollment  ICMJE
 (submitted: September 26, 2008)
150
Actual Study Completion Date  ICMJE June 2014
Actual Primary Completion Date June 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00762710
Other Study ID Numbers  ICMJE 1R01AA017184-01( U.S. NIH Grant/Contract )
5R01AA017184-05 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Seattle Institute for Biomedical and Clinical Research
Study Sponsor  ICMJE Seattle Institute for Biomedical and Clinical Research
Collaborators  ICMJE
  • National Institute on Alcohol Abuse and Alcoholism (NIAAA)
  • VA Puget Sound Health Care System
  • University of Washington
Investigators  ICMJE
Principal Investigator: Tracy L Simpson, Ph.D. VA Puget Sound Health Care System
PRS Account Seattle Institute for Biomedical and Clinical Research
Verification Date June 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP