- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02173041
Impact of Prevention Awareness Group (PAG) on Treatment Attendance and Drug Abstinence Among Substance User
May 15, 2015 updated by: Macmillan Research Group UK
Impact of Prevention Awareness Group (PAG) on Treatment Attendance and Drug Abstinence Among Substance User: Results of the Randomized Controlled Trial
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.
Study Overview
Status
Completed
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
152
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Rajasthan
-
Bai, Nawalgarh, Rajasthan, India
- Gyansanjeevani
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Other: Standard Usual Care
Community program which follows with referral services
|
|
|
Experimental: Prevention Awareness Groups (PAG)
Prevention Awareness Groups (PAG) is a community based integrated substance abuse prevention program targeting vulnerable populations.
It comprises of community programs, physician led counseling followed by treatment follow up in community based clinic.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Treatment attendance
Time Frame: Change from baseline to six month
|
Change from baseline to six month
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Drug abstinence
Time Frame: Change from baseline to six month
|
Change from baseline to six month
|
Other Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Quality of Life assessed by General Health Questionnaire (GHQ)
Time Frame: Change from baseline to six months
|
Change from baseline to six months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Neha Sharma, PhD, NMP Medical Research Institute
- Study Director: Valerie Murray, MA, Goldington Family Centre
- Study Chair: Amit Punia, LLB, NMP Medical Research Institute
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
August 1, 2014
Primary Completion (Actual)
March 1, 2015
Study Completion (Actual)
April 1, 2015
Study Registration Dates
First Submitted
June 22, 2014
First Submitted That Met QC Criteria
June 22, 2014
First Posted (Estimate)
June 24, 2014
Study Record Updates
Last Update Posted (Estimate)
May 18, 2015
Last Update Submitted That Met QC Criteria
May 15, 2015
Last Verified
May 1, 2015
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- Mac/NMP 1216
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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