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Impact of Prevention Awareness Group (PAG) on Treatment Attendance and Drug Abstinence Among Substance User

Primary Purpose

Substance Use Disorder, Drug Dependence,, Alcohol Dependence

Status
Completed
Phase
Not Applicable
Locations
India
Study Type
Interventional
Intervention
Prevention Awareness Groups (PAG)
Standard Care
Sponsored by
Macmillan Research Group UK
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Substance Use Disorder focused on measuring Prevention and Awareness Groups (PAG),, Substance Use Disorder,, Community based intervention

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • GyanSanjeevani

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Experimental

Arm Label

Standard Usual Care

Prevention Awareness Groups (PAG)

Arm Description

Community program which follows with referral services

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.

Outcomes

Primary Outcome Measures

Treatment attendance

Secondary Outcome Measures

Drug abstinence

Full Information

First Posted
June 22, 2014
Last Updated
May 15, 2015
Sponsor
Macmillan Research Group UK
Collaborators
NMP Medical Research Institute, Warwick Research Services
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1. Study Identification

Unique Protocol Identification Number
NCT02173041
Brief Title
Impact of Prevention Awareness Group (PAG) on Treatment Attendance and Drug Abstinence Among Substance User
Official Title
Impact of Prevention Awareness Group (PAG) on Treatment Attendance and Drug Abstinence Among Substance User: Results of the Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
May 2015
Overall Recruitment Status
Completed
Study Start Date
August 2014 (undefined)
Primary Completion Date
March 2015 (Actual)
Study Completion Date
April 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Macmillan Research Group UK
Collaborators
NMP Medical Research Institute, Warwick Research Services

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Substance Use Disorder, Drug Dependence,, Alcohol Dependence
Keywords
Prevention and Awareness Groups (PAG),, Substance Use Disorder,, Community based intervention

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
152 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Standard Usual Care
Arm Type
Other
Arm Description
Community program which follows with referral services
Arm Title
Prevention Awareness Groups (PAG)
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Prevention Awareness Groups (PAG)
Intervention Type
Other
Intervention Name(s)
Standard Care
Primary Outcome Measure Information:
Title
Treatment attendance
Time Frame
Change from baseline to six month
Secondary Outcome Measure Information:
Title
Drug abstinence
Time Frame
Change from baseline to six month
Other Pre-specified Outcome Measures:
Title
Quality of Life assessed by General Health Questionnaire (GHQ)
Time Frame
Change from baseline to six months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Valerie Murray, MA
Organizational Affiliation
Goldington Family Centre
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Neha Sharma, PhD
Organizational Affiliation
NMP Medical Research Institute
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Amit Punia, LLB
Organizational Affiliation
NMP Medical Research Institute
Official's Role
Study Chair
Facility Information:
Facility Name
GyanSanjeevani
City
Bai, Nawalgarh
State/Province
Rajasthan
Country
India

12. IPD Sharing Statement

Learn more about this trial

Impact of Prevention Awareness Group (PAG) on Treatment Attendance and Drug Abstinence Among Substance User

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