NCT01580163

Brief Summary

The purpose of this research is to observe the efficacy of comprehensive treatment model to improve treatment compliance and relapse prevention.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
554

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2009

Longer than P75 for not_applicable

Geographic Reach
1 country

2 active sites

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

September 1, 2009

Completed
2.6 years until next milestone

First Submitted

Initial submission to the registry

April 17, 2012

Completed
1 day until next milestone

First Posted

Study publicly available on registry

April 18, 2012

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2013

Completed
Last Updated

November 18, 2015

Status Verified

November 1, 2015

Enrollment Period

3.9 years

First QC Date

April 17, 2012

Last Update Submit

November 16, 2015

Conditions

Heroin Addiction

Keywords

the opioid dependence in rehabilitation phasecommunity

Outcome Measures

Primary Outcomes (1)

  • The drug use pattern during observation period

    The investigator will ues NHI(Nature History Interview) to describe the drug use pattern and and compare the different change among different groups during observation period

    Baseline ,26 weeks and 52 weeks

Secondary Outcomes (4)

  • The change of ASI(Addiction Severity Index) after the treatment and observation

    Baseline,26weeks and 52 weeks

  • the change of drug use pattern during observation period

    Baseline,26weeks and 52 weeks

  • the change of SF-36(the MOS item short form health survey) after treatment and observation

    Baseline,26 weeks and 52 weeks

  • the change of SAS(Self-Rating Anxiety Scale) and SDS(Self-rating Depression Scale) during observation period

    Baseline ,26weeks and 52 weeks

Study Arms (3)

JITAI combined therapy group

EXPERIMENTAL

The investigator will adopt JITAI combined psychological intervention and social support in Shanghai-related community.

Drug: JITAI Combined with psychological intervention

Methadone combined herapy group

EXPERIMENTAL

The investigator will adopt JITAI combined psychological intervention and social support in Shanghai-related community.

Drug: Methadone

JITAI therapy group

EXPERIMENTAL

The investigator will adopt JITAI combined social support in Shanghai-related community and outside of Shanghai.

Drug: Traditional Chinese Medicine JITAI

Interventions

JITAI Combined with psychological interventionDRUG

tablet，Each tablet weight 0.4g

JITAI combined therapy group
MethadoneDRUG

Oral Solution，1mg/ml

Methadone combined herapy group
Traditional Chinese Medicine JITAIDRUG

tablet，Each tablet weight 0.4g

Also known as: JITAI
JITAI therapy group

Eligibility Criteria

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

You may qualify if:

  • Clinical Diagnosis of The opioid dependence
  • After detoxification.

You may not qualify if:

  • Clinical Diagnosis of glaucoma and other severe mental disorder；
  • serious organic disease within three months；
  • can not comply with the test requirements；
  • accept Hans therapy instrument；
  • have tendence of suicide，self-injury and impulse；
  • ECG abnormalities；
  • ALT or AST greater than 5 times the upper limit of normal；
  • history of epilepsy；
  • Lactating or pregnant women，or women of childbearing age fails to take effective contraceptive measures；
  • serious history of drug allergy or known allergy on traditional Chinese medicine JITAI；
  • Study before the withdrawal less than a half-life of 5.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

National Institute on Drug Dependence，Peking University

Beijing, Beijing Municipality, China

Location

The Second Xiangya Hospital of Central South University

Changsha, Hunan, China

Location

MeSH Terms

Conditions

Heroin Dependence

Interventions

Psychosocial InterventionMethadone

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

PsychotherapyBehavioral Disciplines and ActivitiesKetonesOrganic Chemicals

Study Officials

  • Min ZHAO, Ph.D.

    Shanghai Mental Health Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
vise president

Study Record Dates

First Submitted

April 17, 2012

First Posted

April 18, 2012

Study Start

September 1, 2009

Primary Completion

August 1, 2013

Study Completion

August 1, 2013

Last Updated

November 18, 2015

Record last verified: 2015-11

Locations

CN(2)