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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
National Institute on Drug Abuse (NIDA)
Information provided by (Responsible Party):
Rajita Sinha, Yale University
ClinicalTrials.gov Identifier:
NCT00585754
First received: December 22, 2007
Last updated: September 17, 2012
Last verified: September 2012
History of Changes
  Purpose

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.


Condition Intervention Phase
Cocaine Dependent
Alcohol Dependent
 Drug: Guanfacine
Drug: Placebo
 Phase 1

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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Yale University:

Primary Outcome Measures:
  • stress-induced cocaine craving and negative emotions [ Time Frame: 5 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Drug and alcohol use [ Time Frame: over ninety days ] [ Designated as safety issue: No ]

Estimated Enrollment: 60
Study Start Date: April 2006
Estimated Study Completion Date: December 2012
Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Guanfacine Drug: Guanfacine
1.5mg BID
Placebo Comparator: PLA Drug: Placebo
placebo

  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00585754

Locations
United States, Connecticut
Yale University School of Medicine: Research Prog. on Stress, Addiction, and Psychopathology
New Haven, Connecticut, United States, 06519
Sponsors and Collaborators
Yale University
National Institute on Drug Abuse (NIDA)
Investigators
Principal Investigator: Rajita Sinha, PhD Yale University
  More Information

No publications provided

Responsible Party: Rajita Sinha, Professor, Yale University
ClinicalTrials.gov Identifier: NCT00585754     History of Changes
Other Study ID Numbers: 0512000886, R01DA027130
Study First Received: December 22, 2007
Last Updated: September 17, 2012
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Guanfacine
Antihypertensive Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions
Adrenergic alpha-2 Receptor Agonists
 Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on May 16, 2013