Entry Into Comprehensive Methadone Treatment Via Interim Maintenance - Full Text View

Sponsors and Collaborators:	Friends Research Institute, Inc. National Institute on Drug Abuse (NIDA)
Information provided by:	Friends Research Institute, Inc.
ClinicalTrials.gov Identifier:	NCT00712036

Purpose

The purpose of the study is to determine whether one of three levels of counseling intensity will be associated with better treatment outcomes when combined with methadone maintenance treatment for heroin-addicted adults drawn from a methadone treatment program waiting list.

Condition	Intervention
Opioid Dependency	Behavioral: Interim Behavioral: Comprehensive Behavioral: Restored

Drug Information available for: Methadone Methadone hydrochloride Diacetylmorphine Diacetylmorphine hydrochloride

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Parallel Assignment, Efficacy Study
Official Title:	Entry Into Comprehensive Methadone Treatment Via Interim Maintenance

Further study details as provided by Friends Research Institute, Inc.:

Primary Outcome Measures:

Opioid positive drug tests [ Time Frame: 4 and 12 months post-baseline ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

HIV risk behavior [ Time Frame: 4 and 12 months post-baseline ] [ Designated as safety issue: No ]
Treatment Retention [ Time Frame: 4 and 12 months post-baselin ] [ Designated as safety issue: No ]
Cost-benefit [ Time Frame: 12 months post-baseline ] [ Designated as safety issue: No ]
Cocaine positive tests [ Time Frame: 4 and 12 months post-baseline ] [ Designated as safety issue: No ]

Estimated Enrollment:	300
Study Start Date:	June 2008
Estimated Study Completion Date:	May 2011
Estimated Primary Completion Date:	October 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Interim: Active Comparator Methadone maintenance for up to 4 months with emergency counseling only for individuals on program waiting lists.	Behavioral: Interim Methadone maintenance with emergency counseling only for up to 4 months
Comprehensive: Active Comparator Methadone Treatment provided with counseling as usual.	Behavioral: Comprehensive Methadone treatment with counseling as usual
Restored: Active Comparator Methadone Treatment with counseling provided by a clinician with a lower caseload than counseling as usual.	Behavioral: Restored Methadone maintenance with counseling provided by a clinician with a lower than usual caseload

Detailed Description:

Waiting lists for methadone treatment programs persist, and new and more effective approaches for expanding treatment access and improving outcomes for heroin dependent individuals are needed. Recently completed research demonstrated that so-called "Interim Methadone Maintenance" (i.e., methadone with crisis counseling only, for individuals on waiting lists) was associated with greater entry into methadone treatment, less self-reported heroin and cocaine use, lower rates of opioid-positive drug tests, and lower rates of self-reported crime. The present study will build on this work by comparing three levels of counseling provided with methadone treatment: 1)"Interim" Methadone Treatment; 2) "Comprehensive" Methadone Treatment (which is the name for the usual amount of counseling provided, i.e., about once per week) and; 3)"Restored" Methadone Treatment in which the counselors will have a lower case load and will be able to provide more attention to their patients.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

adult
meets criteria for methadone maintenance
unable to gain admission to methadone program within 14 days

Exclusion Criteria:

pregnant
acute medical or psychiatric illness

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00712036

Contacts

Contact: Sharon Kelly, Ph.D.

410-837-3977 ext 273

Skelly@frisrc.org

Locations

United States, Maryland
Friends Research Institute	Recruiting
Baltimore, Maryland, United States, 21201
Sub-Investigator: Jerome H Jaffe, M.D.
Sub-Investigator: Sharon Kelly, Ph.D.

Sponsors and Collaborators

Friends Research Institute, Inc.

National Institute on Drug Abuse (NIDA)

Investigators

Principal Investigator:

Robert P Schwartz, M.D.

Friends Research Institute, Inc.

More Information

Publications:

Schwartz RP, Jaffe JH, Highfield DA, Callaman JM, O'Grady KE. A randomized controlled trial of interim methadone maintenance: 10-Month follow-up. Drug Alcohol Depend. 2007 Jan 5;86(1):30-6. Epub 2006 Jun 21.

Schwartz RP, Highfield DA, Jaffe JH, Brady JV, Butler CB, Rouse CO, Callaman JM, O'Grady KE, Battjes RJ. A randomized controlled trial of interim methadone maintenance. Arch Gen Psychiatry. 2006 Jan;63(1):102-9.

Highfield DA, Schwartz RP, Jaffe JH, O'Grady KE. Intravenous and intranasal heroin-dependent treatment-seekers: characteristics and treatment outcome. Addiction. 2007 Nov;102(11):1816-23. Epub 2007 Sep 3.

Responsible Party:	Friends Research Institute ( Robert P. Schwartz, M.D. )
Study ID Numbers:	DA R01 13636
Study First Received:	July 2, 2008
Last Updated:	July 8, 2008
ClinicalTrials.gov Identifier:	NCT00712036
Health Authority:	United States: Institutional Review Board

Keywords provided by Friends Research Institute, Inc.:

Heroin dependence
Interim Methadone Treatment
Counseling

Study placed in the following topic categories:

Naphazoline
Oxymetazoline
Methadone
Guaifenesin

Phenylephrine
Heroin
Heroin Dependence
Phenylpropanolamine

Additional relevant MeSH terms:

Respiratory System Agents
Sensory System Agents
Therapeutic Uses
Physiological Effects of Drugs
Central Nervous System Depressants
Narcotics

Peripheral Nervous System Agents
Analgesics
Antitussive Agents
Central Nervous System Agents
Analgesics, Opioid
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 14, 2009