This is a study of the effects of clonidine: how it affects responses to stress and to things that remind people of drugs. Clonidine is being compared to placebo. Participants listen to taped imagery scripts that invoke neutral, stress, and drug cues. Physiological and psychological measures are collected...
Date First Received: April 25, 2006
Last Updated: June 19, 2008
Verified by: National Institute on Drug Abuse (NIDA), June 2008
Clinical Trial Phase: Phase 1 | Start Date: August 2005
Overall Status: Recruiting
Estimated Enrollment: 160
Brief Summary
Condition Keyword(s):
Intervention(s):
This is a study of the effects of clonidine: how it affects responses to stress and to things that remind people of drugs. Clonidine is being compared to placebo. Participants listen to taped imagery scripts that invoke neutral, stress, and drug cues. Physiological and psychological measures are collected.
Study Type: Interventional
Study Design: Basic Science, Randomized, Double Blind (Subject, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Pharmacodynamics Study
Study Primary Completion Date: August 2010
Intervention(s) in this Clinical Trial
- Drug: Clonidine
- 0.1 or 0.2 mg oral, one dose
- Drug: placebo
- oral capsule 1 dose
Arms, Groups and Cohorts in this Clinical Trial
- Experimental: 1
- Placebo Comparator: 2
Outcome Measures for this Clinical Trial
Primary Measures
- subjective ratings of drug craving and mood
- Time Frame: 1 hr
Safety Issue?: No
- Time Frame: 1 hr
- autonomic response (galvanic skin response [GSR])
- Time Frame: 1 hr
Safety Issue?: No
- Time Frame: 1 hr
- heart rate and blood pressure
- Time Frame: 1 hr
Safety Issue?: No
- Time Frame: 1 hr
- endocrine responses (salivary cortisol and salivary α-amylase)
- Time Frame: 1 hr
Safety Issue?: No
- Time Frame: 1 hr
Criteria for Participation in this Clinical Trial
Inclusion Criteria:
- evidence of cocaine or heroin use
Exclusion Criteria:
- medical or psychiatric disorders that would contraindicate administration of clonidine; medications with known interactions with clonidine
Gender Eligibility for this Clinical Trial: Both
Minimum Age for this Clinical Trial: 18 Years
Maximum Age for this Clinical Trial: 55 Years
Are Healthy Volunteers Accepted for this Clinical Trial?: Accepts Healthy Volunteers
Clinical Trial Sponsor Information
Lead Sponsor: National Institute on Drug Abuse (NIDA)
Overall Clinical Trial Officials and Contacts
Kenzie Preston, Ph.D. Principal Investigator NIDA IRP
Overall Contact: Kenzie Preston, Ph.D. 410-550-1639 kpreston@intra.nida.nih.gov
Additional Information
Information obtained from ClinicalTrials.gov on September 04, 2008
Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00318760
Study ID Number: NIDAIRP403
ClinicalTrials.gov Identifier: NCT00318760
Health Authority: United States: Federal Government
Clinical Trials Authorship and Review
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