NCT01144390

Brief Summary

The purpose of this study is to explore barriers and determine whether optimizing protocol is effective in the treatment of heroin dependence in community-based MMT clinics.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
240

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Apr 2010

Geographic Reach
1 country

4 active sites

Status
unknown

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

April 1, 2010

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

June 11, 2010

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 15, 2010

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2011

Completed
Last Updated

March 11, 2011

Status Verified

March 1, 2011

Enrollment Period

1.2 years

First QC Date

June 11, 2010

Last Update Submit

March 10, 2011

Conditions

Keywords

heroin dependencecommunity-basedMMT

Outcome Measures

Primary Outcomes (1)

  • treatment retention

    retaining patients in the methadone maintenance treatment during and after the study.

    12 months

Secondary Outcomes (1)

  • in-treatment performance.

    12 months

Study Arms (2)

CBT plus MMT

EXPERIMENTAL

cognitive behavioral therapy for heroin addicts with methadone maintenance treatment

Behavioral: cognitive behavioral therapyDrug: methadone maintenance treatment

methadone maintenance treatment

ACTIVE COMPARATOR

methadone maintenance treatment for heroin addicts

Drug: methadone maintenance treatment

Interventions

cognitive behavioral therapy, one session per week and psycho-education lecture in group once per month

CBT plus MMT

methadone maintenance treatment

CBT plus MMTmethadone maintenance treatment

Eligibility Criteria

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

You may qualify if:

  • clinical diagnosis of heroin dependence
  • must be able to take methadone

You may not qualify if:

  • schizophrenia and mood disorder
  • physical disabilities who could not come to take part in psychotherapy sessions.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Mental Health Center of Hongkou District

Shanghai, Shanghai Municipality, 200030, China

Location

Mental Health Center of Pudong District

Shanghai, Shanghai Municipality, 200030, China

Location

Mental Health Center of Xuhui District

Shanghai, Shanghai Municipality, 200030, China

Location

Mental Health Center of Yangpu District

Shanghai, Shanghai Municipality, 200030, China

Location

Related Publications (1)

  • Pan S, Jiang H, Du J, Chen H, Li Z, Ling W, Zhao M. Efficacy of Cognitive Behavioral Therapy on Opiate Use and Retention in Methadone Maintenance Treatment in China: A Randomised Trial. PLoS One. 2015 Jun 24;10(6):e0127598. doi: 10.1371/journal.pone.0127598. eCollection 2015.

MeSH Terms

Conditions

Heroin Dependence

Interventions

Cognitive Behavioral Therapy

Condition Hierarchy (Ancestors)

Opioid-Related DisordersNarcotic-Related DisordersSubstance-Related DisordersChemically-Induced DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Behavior TherapyPsychotherapyBehavioral Disciplines and Activities

Study Officials

  • min ZHAO, Ph.D.

    Shanghai Mental Health Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

June 11, 2010

First Posted

June 15, 2010

Study Start

April 1, 2010

Primary Completion

June 1, 2011

Study Completion

June 1, 2011

Last Updated

March 11, 2011

Record last verified: 2011-03

Locations