Treatment of Heroin and Cocaine With Methadone Maintenance and Contingency Management - Full Text View

Sponsored by:	National Institute on Drug Abuse (NIDA)
Information provided by:	National Institute on Drug Abuse (NIDA)
ClinicalTrials.gov Identifier:	NCT00292110

Purpose

The purpose of this study is to determine if simultaneous abstinence from heroin and cocaine can be elicited by combining two approaches: flexible methadone dosing and voucher-based contingency management in which patients earn incentives for cocaine abstinence.

Condition	Intervention	Phase
Opiate-Related Disorders Cocaine-Related Disorders	Behavioral: Contingency Management Drug: Methadone dose Behavioral: Contingency management/Noncontingent incentives Drug: Methadone	Phase II

Drug Information available for: Methadone Methadone hydrochloride 8-Azabicyclo(3.2.1)octane-2-carboxylic acid, 3-(benzoyloxy)-8-methyl-, methyl ester, (1R-(exo,exo))- Cocaine hydrochloride Diacetylmorphine Diacetylmorphine hydrochloride

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Dose Comparison, Parallel Assignment
Official Title:	Treatment of Heroin and Cocaine With Methadone Maintenance and Contingency Management

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

Primary Outcome Measures:

abstinence from cocaine and heroin [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

time to relapse [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
Psychological and psychosocial outcome [ Time Frame: 50 weeks ] [ Designated as safety issue: No ]
HIV Risk Behaviors [ Time Frame: 50 weeks ] [ Designated as safety issue: No ]
QT interval [ Time Frame: 24 weeks ] [ Designated as safety issue: Yes ]
urine microalbuminuria [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
blood lipid profile [ Time Frame: 50 weeks ] [ Designated as safety issue: No ]
Quality of Life [ Time Frame: 50 weeks ] [ Designated as safety issue: No ]
Substance Dependence [ Time Frame: 50 weeks ] [ Designated as safety issue: No ]
methadone plasma and saliva concentration [ Time Frame: 50 weeks ] [ Designated as safety issue: No ]
cortisol and prolactin levels [ Time Frame: 50 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment:	300
Study Start Date:	December 2004
Estimated Study Completion Date:	January 2012
Estimated Primary Completion Date:	January 2012 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental	Behavioral: Contingency Management incentives given for cocaine abstinence Drug: Methadone dose flexible methadone dosing to 190 mg/day daily orally
2: Active Comparator	Behavioral: Contingency Management incentives given for cocaine abstinence Behavioral: Contingency management/Noncontingent incentives incentives given independent of drug use Drug: Methadone 100 mg/day orally
3: Active Comparator	Drug: Methadone dose flexible methadone dosing to 190 mg/day daily orally
4: Active Comparator	Behavioral: Contingency management/Noncontingent incentives incentives given independent of drug use Drug: Methadone 100 mg/day orally

Eligibility

Ages Eligible for Study:	18 Years to 65 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

physical dependence on opiates; requiring treatment for cocaine use; able to attend clinic seven days per week

Exclusion Criteria:

medical or psychiatric conditions for which methadone is contraindicated; pregnancy; inability to give informed consent

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00292110

Contacts

Contact: Kenzie Preston, PhD

410-550-1639

kpreston@intra.nida.nih.gov

Locations

United States, Maryland
NIDA Intramural Research Program	Recruiting
Baltimore, Maryland, United States, 21224
Principal Investigator: Kenzie Preston, PhD

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 390, Z01 DA 000175
Study First Received:	February 14, 2006
Last Updated:	June 19, 2008
ClinicalTrials.gov Identifier:	NCT00292110
Health Authority:	United States: Federal Government

Study placed in the following topic categories:

Naphazoline
Cocaine-Related Disorders
Oxymetazoline
Methadone
Guaifenesin
Phenylephrine

Heroin
Mental Disorders
Substance-Related Disorders
Disorders of Environmental Origin
Phenylpropanolamine
Cocaine

Additional relevant MeSH terms:

Respiratory System Agents
Disease
Physiological Effects of Drugs
Central Nervous System Depressants
Narcotics
Pharmacologic Actions
Pathologic Processes

Sensory System Agents
Therapeutic Uses
Analgesics
Peripheral Nervous System Agents
Antitussive Agents
Central Nervous System Agents
Analgesics, Opioid

ClinicalTrials.gov processed this record on January 14, 2009