NCT00712036

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
230

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jun 2008

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2008

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

July 2, 2008

Completed
7 days until next milestone

First Posted

Study publicly available on registry

July 9, 2008

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2011

Completed
Last Updated

January 9, 2015

Status Verified

January 1, 2015

Enrollment Period

2.6 years

First QC Date

July 2, 2008

Last Update Submit

January 8, 2015

Conditions

Opiate Dependence

Keywords

Heroin dependenceInterim Methadone TreatmentCounseling

Outcome Measures

Primary Outcomes (1)

  • Opioid positive drug tests

    4 and 12 months post-baseline

Secondary Outcomes (4)

  • HIV risk behavior

    4 and 12 months post-baseline

  • Treatment Retention

    4 and 12 months post-baselin

  • Cost-benefit

    12 months post-baseline

  • Cocaine positive tests

    4 and 12 months post-baseline

Study Arms (3)

Interim

ACTIVE COMPARATOR

Methadone maintenance for up to 4 months with emergency counseling only for individuals on program waiting lists.

Behavioral: Interim

Comprehensive

ACTIVE COMPARATOR

Methadone Treatment provided with counseling as usual.

Behavioral: Comprehensive

Restored

ACTIVE COMPARATOR

Methadone Treatment with counseling provided by a clinician with a lower caseload than counseling as usual.

Behavioral: Restored

Interventions

InterimBEHAVIORAL

Methadone maintenance with emergency counseling only for up to 4 months

Interim
ComprehensiveBEHAVIORAL

Methadone treatment with counseling as usual

Comprehensive
RestoredBEHAVIORAL

Methadone maintenance with counseling provided by a clinician with a lower than usual caseload

Restored

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • pregnant
  • acute medical or psychiatric illness

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Friends Research Institute

Baltimore, Maryland, 21201, United States

Location

Related Publications (7)

  • 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. doi: 10.1016/j.drugalcdep.2006.04.017. Epub 2006 Jun 21.

    PMID: 16793221BACKGROUND

  • 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. doi: 10.1001/archpsyc.63.1.102.

    PMID: 16389204BACKGROUND

  • 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. doi: 10.1111/j.1360-0443.2007.01998.x. Epub 2007 Sep 3.

    PMID: 17784892BACKGROUND

  • Schwartz RP, Kelly SM, O'Grady KE, Gandhi D, Jaffe JH. Interim methadone treatment compared to standard methadone treatment: 4-month findings. J Subst Abuse Treat. 2011 Jul;41(1):21-9. doi: 10.1016/j.jsat.2011.01.008. Epub 2011 Feb 24.

    PMID: 21353445BACKGROUND

  • Schwartz RP, Alexandre PK, Kelly SM, O'Grady KE, Gryczynski J, Jaffe JH. Interim versus standard methadone treatment: a benefit-cost analysis. J Subst Abuse Treat. 2014 Mar;46(3):306-14. doi: 10.1016/j.jsat.2013.10.003. Epub 2013 Oct 14.

    PMID: 24239030RESULT

  • Schwartz RP, Kelly SM, O'Grady KE, Gandhi D, Jaffe JH. Randomized trial of standard methadone treatment compared to initiating methadone without counseling: 12-month findings. Addiction. 2012 May;107(5):943-52. doi: 10.1111/j.1360-0443.2011.03700.x. Epub 2012 Feb 11.

    PMID: 22029398RESULT

  • Kelly SM, Schwartz RP, O'grady KE, Gandhi D, Jaffe JH. Impact of methadone with versus without drug abuse counseling on HIV risk: 4- and 12-month findings from a clinical trial. J Addict Med. 2012 Jun;6(2):145-52. doi: 10.1097/ADM.0b013e31823ae556.

    PMID: 22134175RESULT

MeSH Terms

Conditions

Opioid-Related DisordersHeroin Dependence

Interventions

Denture, Partial, Temporary

Condition Hierarchy (Ancestors)

Narcotic-Related DisordersSubstance-Related DisordersChemically-Induced DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Denture, PartialDenturesDental ProsthesisProsthodonticsDentistryProstheses and ImplantsEquipment and Supplies

Study Officials

  • Robert P Schwartz, M.D.

    Friends Research Institute, Inc.

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 2, 2008

First Posted

July 9, 2008

Study Start

June 1, 2008

Primary Completion

January 1, 2011

Study Completion

January 1, 2011

Last Updated

January 9, 2015

Record last verified: 2015-01

Locations

US(1)