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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2012 by Yale University.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
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

December 22, 2007
September 17, 2012
April 2006
December 2012   (final data collection date for primary outcome measure)
stress-induced cocaine craving and negative emotions [ Time Frame: 5 years ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00585754 on ClinicalTrials.gov Archive Site
Drug and alcohol use [ Time Frame: over ninety days ] [ Designated as safety issue: No ]
Not Provided
Not Provided
Not Provided
 
Guanfacine to Reduce Stress-Induced Cocaine/Alcohol Craving and Relapse
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.

Not Provided
Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
  • Cocaine Dependent
  • Alcohol Dependent
  • Drug: Guanfacine
    1.5mg BID
  • Drug: Placebo
    placebo
  • Active Comparator: Guanfacine
    Intervention: Drug: Guanfacine
  • Placebo Comparator: PLA
    Intervention: Drug: Placebo
Fox HC, Morgan PT, Sinha R. Sex differences in guanfacine effects on drug craving and stress arousal in cocaine-dependent individuals. Neuropsychopharmacology. 2014 May;39(6):1527-37. doi: 10.1038/npp.2014.1. Epub 2014 Jan 7.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
60
December 2012
December 2012   (final data collection date for primary outcome measure)

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.
Both
18 Years to 50 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00585754
0512000886, R01DA027130
Yes
Rajita Sinha, Yale University
Yale University
National Institute on Drug Abuse (NIDA)
Principal Investigator: Rajita Sinha, PhD Yale University
Yale University
September 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP