Effect of Clonidine on Imagery Scripts

This study is currently recruiting participants.

Verified by National Institute on Drug Abuse (NIDA), June 2008

First Received: April 25, 2006 Last Updated: June 19, 2008 History of Changes

Sponsor:	National Institute on Drug Abuse (NIDA)
Information provided by:	National Institute on Drug Abuse (NIDA)
ClinicalTrials.gov Identifier:	NCT00318760

Purpose

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.

Condition	Intervention	Phase
Cocaine Abuse Heroin Abuse	Drug: Clonidine Drug: placebo	Phase I

Study Type:	Interventional
Study Design:	Basic Science, Randomized, Double Blind (Subject, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Pharmacodynamics Study

Resource links provided by NLM:

Drug Information available for: Clonidine Clonidine hydrochloride

U.S. FDA Resources

Further study details as provided by National Institute on Drug Abuse (NIDA):

Primary Outcome Measures:

subjective ratings of drug craving and mood [ Time Frame: 1 hr ] [ Designated as safety issue: No ]
autonomic response (galvanic skin response [GSR]) [ Time Frame: 1 hr ] [ Designated as safety issue: No ]
heart rate and blood pressure [ Time Frame: 1 hr ] [ Designated as safety issue: No ]
endocrine responses (salivary cortisol and salivary α-amylase) [ Time Frame: 1 hr ] [ Designated as safety issue: No ]

Estimated Enrollment:	160
Study Start Date:	August 2005
Estimated Study Completion Date:	August 2010
Estimated Primary Completion Date:	August 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental	Drug: Clonidine 0.1 or 0.2 mg oral, one dose
2: Placebo Comparator	Drug: placebo oral capsule 1 dose

Eligibility

Ages Eligible for Study:	18 Years to 55 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00318760

Contacts

Contact: Kenzie Preston, Ph.D.

410-550-1639

kpreston@intra.nida.nih.gov

Locations

United States, Maryland
NIDA IRP	Recruiting
Baltimore, Maryland, United States, 21224

Sponsors and Collaborators

National Institute on Drug Abuse (NIDA)

Investigators

Principal Investigator:

Kenzie Preston, Ph.D.

NIDA IRP

More Information

No publications provided

Responsible Party:	National Institute on Drug Abuse ( Kenzie L. Preston, Ph.D., Principal Investigator )
Study ID Numbers:	NIDAIRP403, Z01 DA 000500
Study First Received:	April 25, 2006
Last Updated:	June 19, 2008
ClinicalTrials.gov Identifier:	NCT00318760 History of Changes
Health Authority:	United States: Federal Government

Keywords provided by National Institute on Drug Abuse (NIDA):

stress
drug cue
craving
relapse

Additional relevant MeSH terms:

Cocaine-Related Disorders
Sympatholytics
Neurotransmitter Agents
Adrenergic alpha-Agonists
Adrenergic Agents
Molecular Mechanisms of Pharmacological Action
Heroin Dependence
Physiological Effects of Drugs
Clonidine
Disorders of Environmental Origin
Cardiovascular Agents
Antihypertensive Agents

Opioid-Related Disorders
Adrenergic Agonists
Pharmacologic Actions
Autonomic Agents
Sensory System Agents
Mental Disorders
Therapeutic Uses
Substance-Related Disorders
Peripheral Nervous System Agents
Analgesics
Central Nervous System Agents

ClinicalTrials.gov processed this record on February 08, 2010