Prazosin to Reduce Stress-Induced Alcohol/Drug Craving and Relapse
This study is currently recruiting participants.
Verified September 2012 by Yale University
Sponsor:
Yale University
Collaborator:
Information provided by (Responsible Party):
Rajita Sinha, Yale University
ClinicalTrials.gov Identifier:
NCT00585780
First received: December 25, 2007
Last updated: September 17, 2012
Last verified: September 2012
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Purpose
To test the preliminary efficacy of 16.0 mg of Prazosin daily versus placebo in treatment seeking alcohol dependent individuals. This proposal is a laboratory and treatment outcome study to examine the effects of Prazosin on brief exposure to stress, drug cues and neutral situations on alcohol and drug craving, mood and neurobiological reactivity in a sample of cocaine and/or alcohol dependent individuals. Prazosin will be beneficial for reduction in stress and drug cue induced craving and related arousal. In a sample of 120 alcohol dependent men and women, we propose to examine (a) differences in measures of cocaine craving, emotion state, hypothalamic-pituitary-adrenal (HPA) activation, physiological arousal and plasma catecholamine response to stress imagery and to drug cue imagery as compared to neutral imagery; (b) reduction in alcohol abstinence symptoms; and (c) improvement in alcohol treatment outcomes as measured by increasing abstinence, reduction in alcohol use, increased treatment attendance and decreased relapse risk.
| Condition | Intervention | Phase |
|---|---|---|
|
Alcohol Dependence |
Drug: Prazosin Drug: placebo |
Phase 1 Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator) Primary Purpose: Treatment |
| Official Title: | Prazosin to Reduce Stress-Induced Alcohol/Drug Craving and Relapse |
Resource links provided by NLM:
Further study details as provided by Yale University:
Primary Outcome Measures:
- alcohol and other drug use as measured by weekly urine drug screens/breathalyzer reports and self report of drug use and treatment adherence as measured by frequency of attendance and time to relapse data obtained twice weekly. [ Time Frame: 5 years ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Alcohol craving [ Time Frame: 5 years ] [ Designated as safety issue: No ]
Other Outcome Measures:
- negative mood and anxiety [ Time Frame: 5 years ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 120 |
| Study Start Date: | September 2009 |
| Estimated Study Completion Date: | August 2018 |
| Estimated Primary Completion Date: | August 2017 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: PZ
Prazosin 16 mg/day (tid) will be administered for 12 weeks with contingency management vouchers for treatment attendance and manualized CBT relapse prevention counseling.
|
Drug: Prazosin
three week dose titration schedule at the start of study with the full dose schedule of 5.0mg in the morning, 5.0mg at 3pm, and 11.0mg at bedtime for 8 weeks and then a 5-day taper in week 12.
|
|
Placebo Comparator: PLA
Placebo tablets administered tid for 12 weeks with contingency management vouchers for treatment attendance and manualized CBT relapse prevention counseling.
|
Drug: placebo
placebo
|
Eligibility| Ages Eligible for Study: | 18 Years to 55 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Male or female individuals, ages 18-50, meeting current DSM-IV criteria for alcohol dependence.
- ALCOHOLIC SAMPLE: meet current DSM-IV criteria for alcohol dependence
- COCAINE SAMPLE: meet current DSM-IV criteria for cocaine dependence; documented positive urine toxicology screen for cocaine at intake
- Subject has voluntarily given informed consent and signed the informed consent document.
- Able to read English and complete study evaluations.
Exclusion Criteria:
- Meet current criteria for dependence on another psychoactive substance, excluding nicotine and caffeine;
- Any current use of opiates;
- Current use of any psychoactive drugs, including anxiolytics, antidepressants, naltrexone or disulfram, except for stabilized on SSRIs
- Any psychotic disorder or current Axis I psychiatric symptoms requiring specific attention, including need for psychiatric medications for current major depression and anxiety disorders
- Significant underlying medical conditions such as cerebral, renal, thyroid or cardiac pathology which in the opinion of study physician would preclude patient from fully cooperating or be of potential harm during the course of the study;
- Hypotensive individuals with sitting blood pressure below 100/50 mmHG.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00585780
Contacts
| Contact: Rachel L Hart, MS | 203-737-4791 | rachel.hart@yale.edu |
Locations
| United States, Connecticut | |
| Yale University School of Medicine: Yale Stress Center | Recruiting |
| New Haven, Connecticut, United States, 06519 | |
| Contact: Rachel L Hart, MS 203-737-4791 rachel.hart@yale.edu | |
Sponsors and Collaborators
Yale University
Investigators
| Principal Investigator: | Rajita Sinha, PhD | Yale University |
More Information
No publications provided
| Responsible Party: | Rajita Sinha, Professor, Yale University |
| ClinicalTrials.gov Identifier: | NCT00585780 History of Changes |
| Other Study ID Numbers: | 0705002691, P50-DA016556 |
| Study First Received: | December 25, 2007 |
| Last Updated: | September 17, 2012 |
| Health Authority: | United States: Institutional Review Board |
Additional relevant MeSH terms:
|
Alcoholism Alcohol-Related Disorders Substance-Related Disorders Mental Disorders Prazosin Antihypertensive Agents Cardiovascular Agents Therapeutic Uses |
Pharmacologic Actions Adrenergic alpha-1 Receptor Antagonists Adrenergic alpha-Antagonists Adrenergic Antagonists Adrenergic Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs |
ClinicalTrials.gov processed this record on May 19, 2013