Real-Time Assessment of Drug Craving, Use, and Abstinence During Outpatient Treatment

This study is currently recruiting participants.

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

Sponsored by:	National Institute on Drug Abuse (NIDA)
Information provided by:	National Institute on Drug Abuse (NIDA)
ClinicalTrials.gov Identifier:	NCT00292136

Purpose

The purposes of this study are to determine whether craving, use, and relapse can be prospectively monitored in heroin- and cocaine-abusing outpatients with electronic data-collection devices and to develop methods to monitor different types of relapse in future clinical trials of relapse-prevention medications.

Condition	Intervention	Phase
Opiate Addiction Cocaine Addiction	Drug: Methadone Behavioral: contingency management	Phase I

Drug Information available for: Methadone Methadone hydrochloride

U.S. FDA Resources

Study Type:	Observational
Study Design:	Ecologic or Community, Prospective
Official Title:	Real-Time Assessment of Drug Craving, Use, and Abstinence During Outpatient Treatment: A Development and Feasibility Study

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

Biospecimen Retention: Samples With DNA

Biospecimen Description:

urine specimens

Estimated Enrollment:	250
Study Start Date:	January 2004
Estimated Study Completion Date:	January 2010

Intervention Details:

individualized doses administered daily as oral liquid for duration of the study

incentives given for drug abstinence for 12 weeks

Eligibility

Ages Eligible for Study:	18 Years to 65 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No
Sampling Method:	Non-Probability Sample

Study Population

cocaine and heroin-dependent adults

Criteria

Inclusion Criteria:

physical dependence on opiates; documented use of cocaine

Exclusion Criteria:

significant medical or psychiatric disease that is contraindicated in methadone maintenance
inability to give informed consent
inability to attend the methadone maintenance clinic seven days per week
physical dependence on alcohol or sedatives

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00292136

Contacts

Contact: Kenzie Preston, PhD

443-740-2326

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 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 385, Z01 DA 000175, Z01 DA 000500
Study First Received:	February 14, 2006
Last Updated:	October 3, 2008
ClinicalTrials.gov Identifier:	NCT00292136
Health Authority:	United States: Federal Government

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

relapse
ecological momentary assessment

Study placed in the following topic categories:

Cocaine-Related Disorders
Methadone
Compulsive Behavior
Behavior, Addictive
Mental Disorders

Substance-Related Disorders
Disorders of Environmental Origin
Impulsive Behavior
Opioid-Related Disorders

ClinicalTrials.gov processed this record on January 30, 2009