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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02173041
Other study ID # Mac/NMP 1216
Secondary ID
Status Completed
Phase N/A
First received June 22, 2014
Last updated May 15, 2015
Start date August 2014
Est. completion date April 2015

Study information

Verified date May 2015
Source Macmillan Research Group UK
Contact n/a
Is FDA regulated No
Health authority India: Indian Council of Medical Research
Study type Interventional

Clinical Trial Summary

Substance Use Disorder has been showing a rising trend all over the world including India. The project tested whether a Integrated community wide effort of Prevention and Awareness Groups (PAG) to manage substance use would have a greater effect on treatment attendance and drug abstinence than a de-addiction program alone.


Recruitment information / eligibility

Status Completed
Enrollment 152
Est. completion date April 2015
Est. primary completion date March 2015
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 65 Years
Eligibility Inclusion Criteria:

- suburban, rural Population

- Drug and/or alcohol dependency (DSM-IV substance use disorders criteria)

Exclusion Criteria:

- Did not consent to participate

- Planning to move or relocate

- Severe mental disorder

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment


Intervention

Other:
Prevention Awareness Groups (PAG)

Standard Care


Locations

Country Name City State
India GyanSanjeevani Bai, Nawalgarh Rajasthan

Sponsors (3)

Lead Sponsor Collaborator
Macmillan Research Group UK NMP Medical Research Institute, University of Warwick

Country where clinical trial is conducted

India, 

Outcome

Type Measure Description Time frame Safety issue
Other Quality of Life assessed by General Health Questionnaire (GHQ) Change from baseline to six months No
Primary Treatment attendance Change from baseline to six month No
Secondary Drug abstinence Change from baseline to six month No
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