Completed

NCT Number: NCT00585754

Guanfacine to Reduce Stress-Induced Cocaine/Alcohol Craving and Relapse

This study aims to test the preliminary efficacy of 3.0 mg of guanfacine (GFC) daily versus placebo in cocaine and/or alcohol dependent individuals. This proposal is a laboratory and treatment outcome study to examine the effects of guanfacine 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. Guanfacine 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. Hypothesis 1: Guanfacine will decrease stress-induced cocaine craving, negative emotions and related arousal in the laboratory as compared to placebo. Hypothesis 2a: As compared to the PLA group, the GFC group will show significant reductions in protracted withdrawal symptoms as measured by the CSSA/CIWA during the 9-week treatment period.

Hypothesis 2b: As compared to the PLA group, a higher percentage of the GFC patients will remain abstinent during the 9-week treatment period with a higher percent of negative cocaine urines and alcohol-free days.

Hypothesis 2c: The GFC group will show greater adherence to treatment as measured by the days in treatment as compared to the Pla group.

Completed

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Key information

Conditions

Cocaine Dependent Alcohol Dependent

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Yale University School of Medicine: Yale Stress Center

New Haven, Connecticut, 06519, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Male or female individuals, ages 18 and above, 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.

Treatment and study plan

Guanfacine

Drug

1.5mg BID

Placebo

Drug

placebo

Primary outcomes

stress-induced cocaine craving and negative emotions

Time frame: 5 years

Secondary outcomes

Drug and alcohol use

Time frame: over ninety days

Sponsors and collaborators

Lead sponsor

Yale University

Other

Collaborators

National Institute on Drug Abuse (NIDA)

Registry information

Important dates

Study start: 2006
Primary completion: 2016
Study completion: 2016
First posted: Jan 3, 2008
Registry last updated: Nov 30, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.