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

• Sponsor: Macmillan Research Group UK (Industry)
• Overall Status: Completed
• CT.gov ID: NCT02173041
• Collaborator: NMP Medical Research Institute (Other), Warwick Research Services (Other)
• Enrollment: 152
• Location: 1
• Arms: 2
• Duration (Months): 8
• Patients Per Site Per Month: 19

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Substance Use Disorder; Drug Dependence,; Alcohol Dependence	Other: Prevention Awareness Groups (PAG); Other: Standard Care	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 152 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Impact of Prevention Awareness Group (PAG) on Treatment Attendance and Drug Abstinence Among Substance User: Results of the Randomized Controlled Trial
• Study Start Date: Aug 1, 2014
• Actual Primary Completion Date: Mar 1, 2015
• Actual Study Completion Date: Apr 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
Other: Standard Usual Care Community program which follows with referral services	Other: Standard Care
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.	Other: Prevention Awareness Groups (PAG)

Outcome Measures

Primary Outcome Measures

1. Treatment attendance [Change from baseline to six month]

Secondary Outcome Measures

1. Drug abstinence [Change from baseline to six month]

Other Outcome Measures

1. Quality of Life assessed by General Health Questionnaire (GHQ) [Change from baseline to six months]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 65 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	GyanSanjeevani	Bai, Nawalgarh	Rajasthan	India

Sponsors and Collaborators

• Macmillan Research Group UK
• NMP Medical Research Institute
• Warwick Research Services

Investigators

• Study Director: Valerie Murray, MA, Goldington Family Centre
• Principal Investigator: Neha Sharma, PhD, NMP Medical Research Institute
• Study Chair: Amit Punia, LLB, NMP Medical Research Institute

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Macmillan Research Group UK
• ClinicalTrials.gov Identifier: NCT02173041
• Other Study ID Numbers: Mac/NMP 1216
• First Posted: Jun 24, 2014
• Last Update Posted: May 18, 2015
• Last Verified: May 1, 2015

• Keywords provided by Macmillan Research Group UK: Prevention and Awareness Groups (PAG),; Substance Use Disorder,; Community based intervention
• Additional relevant MeSH terms: Substance-Related Disorders; Alcoholism

Study Results

No Results Posted as of May 18, 2015