Study of the Medication Prazosin for Alcohol Dependence
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| ClinicalTrials.gov Identifier: NCT00762710 |
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Recruitment Status :
Completed
First Posted : September 30, 2008
Results First Posted : June 4, 2020
Last Update Posted : June 4, 2020
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| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Alcoholism | Drug: Prazosin medication Drug: Placebo medication | Phase 2 |
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 : | Interventional (Clinical Trial) |
| Actual Enrollment : | 92 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Double (Participant, Outcomes Assessor) |
| Primary Purpose: | Treatment |
| Official Title: | Clinical Trial of the Adrenergic Alpha-1 Antagonist Prazosin for Alcohol Dependence |
| Actual Study Start Date : | January 2008 |
| Actual Primary Completion Date : | June 2014 |
| Actual Study Completion Date : | June 2014 |
| Arm | Intervention/treatment |
|---|---|
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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.
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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 |
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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.
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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 |
- 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
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00762710
| United States, Washington | |
| VA Puget Sound Health Care System | |
| Seattle, Washington, United States, 98108 | |
| Principal Investigator: | Tracy L Simpson, Ph.D. | VA Puget Sound Health Care System |
Documents provided by Seattle Institute for Biomedical and Clinical Research:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Seattle Institute for Biomedical and Clinical Research |
| ClinicalTrials.gov Identifier: | NCT00762710 |
| Other Study ID Numbers: |
1R01AA017184-01 ( U.S. NIH Grant/Contract ) 5R01AA017184-05 ( U.S. NIH Grant/Contract ) |
| First Posted: | September 30, 2008 Key Record Dates |
| Results First Posted: | June 4, 2020 |
| Last Update Posted: | June 4, 2020 |
| Last Verified: | June 2020 |
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Alcohol Abuse Use Disorder Dependence Symptoms Alcoholic Alcoholism Prazosin Drug Medicine Medication |
Treatment Study Placebo Medical Management Craving Consumption Binge Drinking Drink Heavy |
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Alcoholism Alcohol-Related Disorders Substance-Related Disorders Chemically-Induced Disorders Mental Disorders Prazosin Antihypertensive Agents |
Adrenergic alpha-1 Receptor Antagonists Adrenergic alpha-Antagonists Adrenergic Antagonists Adrenergic Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs |