Conditions:
To test the preliminary efficacy of 16.0 mg of Prazosin daily versus placebo in treatment seeking cocaine and/or 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 cocaine/alcohol 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 60 cocaine and/or 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 cocaine/alcohol abstinence symptoms; and (c) improvement in cocaine and alcohol treatment outcomes as measured by increasing abstinence, reduction in cocaine/alcohol use and increased treatment attendance.
Dates: August 2007 -
Study Status: Recruiting
Ages Eligible: 18 Years - 50 Years
Gender Eligible: Both
Inclusion Criteria:
- Male or female individuals, ages 18-50, meeting current DSM-IV criteria for cocaine
and/or alcohol dependence.
- COCAINE SAMPLE: meet current DSM-IV criteria for cocaine dependence; documented
positive urine toxicology screen for cocaine at intake
- ALCOHOLIC SAMPLE: meet current DSM-IV criteria for alcohol dependence
- 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 or past history of opiate abuse/dependence;
- Current use of any psychoactive drugs, including anxiolytics, antidepressants,
naltrexone or antabuse;
- 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;
- Abstinent from cocaine for more than two weeks prior to admission.
- Hypotensive individuals with sitting blood pressure below 90/50 mmHG.
Sponsors:
Phase: Phase 1
First Received: December 25, 2007
Last Updated: Feb 04, 2009
Clinicaltrials.gov ID:
NCT00585780
Study HIC # 0705002691
Conditions:
Interventions: Drug: Prazosin;
Drug: placebo
To test the preliminary efficacy of 16.0 mg of Prazosin daily versus placebo in treatment seeking cocaine and/or 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 cocaine/alcohol 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 60 cocaine and/or 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 cocaine/alcohol abstinence symptoms; and (c) improvement in cocaine and alcohol treatment outcomes as measured by increasing abstinence, reduction in cocaine/alcohol use and increased treatment attendance.
Dates: August 2007 -
Study Status: Recruiting
Ages Eligible: 18 Years - 50 Years
Gender Eligible: Both
Inclusion Criteria:
- Male or female individuals, ages 18-50, meeting current DSM-IV criteria for cocaine
and/or alcohol dependence.
- COCAINE SAMPLE: meet current DSM-IV criteria for cocaine dependence; documented
positive urine toxicology screen for cocaine at intake
- ALCOHOLIC SAMPLE: meet current DSM-IV criteria for alcohol dependence
- 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 or past history of opiate abuse/dependence;
- Current use of any psychoactive drugs, including anxiolytics, antidepressants,
naltrexone or antabuse;
- 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;
- Abstinent from cocaine for more than two weeks prior to admission.
- Hypotensive individuals with sitting blood pressure below 90/50 mmHG.
Sponsors:
Phase: Phase 1
First Received: December 25, 2007
Last Updated: Feb 04, 2009
Clinicaltrials.gov ID:
NCT00585780
Study HIC # 0705002691
Keri L Bergquist, Psy.D.
203-974-7360
keri.bergquist@yale.edu
Sinha, Rajita
Principal Investigator
HIC # 0805003779
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