Clonidine for Prevention of Relapse to Opiate Abuse

This study is currently recruiting participants.

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

Sponsored by:	National Institute on Drug Abuse (NIDA)
Information provided by:	National Institute on Drug Abuse (NIDA)
ClinicalTrials.gov Identifier:	NCT00295308

Purpose

The purpose of the study is to determine whether clonidine, given to abstinent patients maintainedon buprenorphine, prevents relapse to opioid use more effectively than placebo.

Condition	Intervention	Phase
Opioid-Related Disorders	Drug: Clonidine Drug: placebo	Phase I

Drug Information available for: Clonidine Buprenorphine Buprenorphine hydrochloride Clonidine hydrochloride

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment
Official Title:	Clonidine for Relapse Prevention in Buprenorphine-Maintenance Patients

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

Primary Outcome Measures:

Opiate-negative urine screens [ Time Frame: 38 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

HIV risk behaviors [ Time Frame: 38 weeks ] [ Designated as safety issue: No ]
craving [ Time Frame: 18 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment:	300
Study Start Date:	September 2006
Estimated Study Completion Date:	September 2010
Estimated Primary Completion Date:	September 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental	Drug: Clonidine clonidine up to 0.3 mg/day oral
2: Placebo Comparator	Drug: placebo oral capsules daily

Eligibility

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

Criteria

Inclusion Criteria:

physical dependence on illicit opioids
seeking treatment for opioid dependence
able to attend clinic 7 days/week

Exclusion Criteria:

any medical or psychiatric condition that would compromise participation in the study or contraindicate administration of clonidine or buprenorphine
pregnancy or breast feeding
cognitive impairment that would cause inability to give informed consent
allergy or intolerance to buprenorphine or clonidine
currently taking any medications that are contraindicated with clonidine or buprenorphine

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00295308

Contacts

Contact: Kenzie L Preston, PhD

410-550-1639

kpreston@intra.nida.nih.gov

Locations

United States, Maryland
NIDA Intramural Research Program	Recruiting
Baltimore, Maryland, United States, 21224

Sponsors and Collaborators

National Institute on Drug Abuse (NIDA)

Investigators

Principal Investigator:

Kenzie L Preston, PhD

NIDA Intramural Research Program

More Information

Responsible Party:	National Institute on Drug Abuse ( Kenzie L. Preston, Ph.D., Principal Investigator )
Study ID Numbers:	NIDAIRP 407, Z01 DA 000500
Study First Received:	February 22, 2006
Last Updated:	June 19, 2008
ClinicalTrials.gov Identifier:	NCT00295308
Health Authority:	United States: Federal Government

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

clonidine
relapse
buprenorphine
opioid abstinence
opioid dependence

Study placed in the following topic categories:

Buprenorphine
Mental Disorders
Clonidine
Substance-Related Disorders

Disorders of Environmental Origin
Opioid-Related Disorders
Recurrence

Additional relevant MeSH terms:

Sympatholytics
Neurotransmitter Agents
Disease Attributes
Adrenergic alpha-Agonists
Molecular Mechanisms of Pharmacological Action
Adrenergic Agents
Physiological Effects of Drugs
Narcotic Antagonists
Central Nervous System Depressants
Narcotics
Cardiovascular Agents

Antihypertensive Agents
Adrenergic Agonists
Pharmacologic Actions
Pathologic Processes
Autonomic Agents
Sensory System Agents
Therapeutic Uses
Analgesics
Peripheral Nervous System Agents
Central Nervous System Agents
Analgesics, Opioid

ClinicalTrials.gov processed this record on January 16, 2009