Prazosin for ETOH or Cocaine Craving

Alcoholism Clinical Trial

Official title:

The Role of the Alpha 1-adrenergic Antagonist, Prazosin, in the Reduction of Craving and Relapse in Alcohol and Cocaine-dependent Individuals: a Double-blind, Randomized, Controlled Clinical Trial

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00240227
• Other study ID #: REAP 05-0020
• Status: Terminated
• Phase: N/A
• Start date: April 2004
• Est. completion date: January 2009

Study information

• Verified date: August 2018
• Source: VA Office of Research and Development
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This double-blind placebo controlled crossover pilot trial will test the hypothesis that prazosin, an alpha-1 adrenergic receptor antagonist, reduces craving for their drug of choice in cocaine-dependent and alcohol-dependent veterans. Both the study medication period and the placebo period are each 4 weeks in duration.

Description:

1. Objective of the project: To evaluate the efficacy of prazosin on the reduction of craving in alcohol and cocaine dependent individuals. The investigators hypothesize that prazosin will be more effective than placebo in the reduction of craving that is stimulated by exposure to visual cues or to intolerance to stress in individuals dependent on cocaine and in individuals dependent on alcohol.

Specifically, the investigators hypothesize that in this laboratory study:

• Subjects in the prazosin condition will report a reduction in craving induced in the laboratory by exposure to visual cues compared to subjects in the placebo condition.

• Subjects in the prazosin condition will show less reaction of the noradrenergic system when craving is induced in the laboratory by exposure to visual cues compared to subjects in the placebo condition.

• Subjects will be less likely to relapse to their drug of choice while they are in the prazosin condition compared to when they are in the placebo condition. Most individuals who are able to achieve sobriety in chemical dependency treatment eventually relapse. Until the investigators can prevent the cravings for drugs, which usually precedes relapse, it is unlikely that the investigators will have more effective treatment for drug addiction. Our final hypothesis is that the alpha-1, adrenergic antagonist, prazosin, will prove to be an effective pharmacological agent for treatment of drug dependency.

2. Research plan study design: The proposed study will be a double-blind, placebo-controlled, crossover study of prazosin in subjects who are either dependent on alcohol or on cocaine, and who have been able to achieve one month of sobriety while in intensive outpatient treatment. The double-blind, crossover protocol will last 8 weeks and will include 32 subjects; 16 of whom are alcohol-dependent, and 16 of whom are cocaine-dependent. The focus of this first study will be on subjective and physiological measures of craving that will be induced in a controlled setting by exposure to visual cues.

3. Methodology Setting: This study will occur in room 6A-107 in Building 1 at the Veterans Administration Puget Sound Health Care System in Seattle. This is a soundproof room specifically designed and constructed for studies of this type. Participants: 16 alcohol-dependent adults and 16 cocaine-dependent adults presenting for chemical dependency treatment at the VA Puget Sound Health Care System (VAPSHCS) Addiction Treatment Center. Study Procedures: Once potential subjects have provided their consent to participate in the study, they will undergo a 2 hour baseline assessment that consists of some pencil and paper questionnaires, providing a medical and psychiatric history, and a physical exam. They will provide blood for some basic screening labs to insure they are healthy enough to proceed with the study, and have their baseline vital signs measured. Veterans who are screened for the study will then be enrolled once their lab results and the screening process have determined that they do not meet any medical exclusion criteria. At that point, participants will be randomized to either the study medication or placebo. During the course of the study, participants continue with their outpatient chemical dependency treatment through the Addiction Treatment Center at the VA Puget Sound. During the eight weeks of the study, participants will have weekly orthostatic vital sign and adverse events monitoring by the study nurse or physician. All serious or unexpected adverse events will be reported to the FDA and UW Human Subjects Committee in accordance with requirements. Participants will also provide self-reports of drug or alcohol use and urine drug analysis specimens at these weekly visits. At the end of week 4, each participant will be tested in a 1 hour craving session in room 6A-107 at VA Puget Sound. Subjects will have their heart rate and skin conductance response continuously measured, and have their blood pressure measured every 5 minutes. They will be shown 5 1-minute films, 3 of which are designed to be neutral and 2 of which are designed to provoke craving for their drug of choice. They will be asked to complete a subjective scale of craving prior to each video and after the last video. Participants will not be permitted to leave the craving lab after the last film, until they feel that they have subjectively returned to a level of normal physiological arousal and are no longer experiencing any craving.

4. Findings: No findings to date.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 8
• Est. completion date: January 2009
• Est. primary completion date: January 2009
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

• Age 18-70 years

• Current DSM-IV diagnosis of alcohol dependence or cocaine dependence with no use in last 30 days

• Capacity to provide informed consent

• Actively enrolled in chemical dependency treatment at VA Puget Sound English fluency

Exclusion Criteria:

• Evidence of significant abuse of opiates, PCP, sedatives or anxiolytics

• Suicidal ideation

• DSM IV diagnosis of bipolar mood disorder, schizophrenia or schizoaffective disorder

• Significant acute or chronic medical illness, including unstable angina, recent myocardial infarction, history of congestive heart failure, preexisting hypotension (systolic < 110), or orthostatic hypotension (systolic drop > 20mmHg after two minutes standing or any drop with dizziness), insulin-dependent diabetes mellitus; chronic renal or hepatic failure, pancreatitis, gout, M ni re's disease, benign positional vertigo, narcolepsy

• Concomitant use of alpha-1 antagonists History of prazosin-sensitivity Women who are pregnant, nursing infant(s), or of childbearing potential and not using a contraceptive method judged by the investigator to be effective

• Non-compliance with outpatient chemical dependency treatment

Related Conditions & MeSH terms

• Alcoholism
• Cocaine Dependence
• Cocaine-Related Disorders

Intervention

Drug:
• Prazosin
FDA approved medication for hypertension
• placebo

Locations

Country	Name	City	State
United States	VA Puget Sound Health Care System	Seattle	Washington

Sponsors (1)

Lead Sponsor	Collaborator
US Department of Veterans Affairs

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Skin Conductance Response in Response to Provocative Visual Cues Designed to Elicit Craving, Compared to Placebo Group		During lab session
Secondary	Change in Heart Rate Response in Response to Provocative Visual Cues Designed to Elicit Craving, Compared to Placebo Group		During lab session
Secondary	Change in Blood Pressure Response in Response to Provocative Visual Cues Designed to Elicit Craving, Compared to Placebo Group		During lab session
Secondary	Change in Subjective Experience of Craving in Response to Provocative Visual Cues Designed to Elicit Craving, as Measured by the Within Session Rating for Cocaine/Alcohol Craving		During lab session
Secondary	Change in Self-reports of Substance Use Between Study Medication and Placebo Periods		4 weeks
Secondary	Change in Urine Drug Analysis Results Between Study Medication and Placebo Periods		4 weeks

External Links

•   drugs.com PDR information on the study drug