NCT02173041

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
152

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Aug 2014

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

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

First Submitted

Initial submission to the registry

June 22, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 24, 2014

Completed
1 month until next milestone

Study Start

First participant enrolled

August 1, 2014

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2015

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2015

Completed
Last Updated

May 18, 2015

Status Verified

May 1, 2015

Enrollment Period

7 months

First QC Date

June 22, 2014

Last Update Submit

May 15, 2015

Conditions

Keywords

Prevention and Awareness Groups (PAG),Substance Use Disorder,Community based intervention

Outcome Measures

Primary Outcomes (1)

  • Treatment attendance

    Change from baseline to six month

Secondary Outcomes (1)

  • Drug abstinence

    Change from baseline to six month

Other Outcomes (1)

  • Quality of Life assessed by General Health Questionnaire (GHQ)

    Change from baseline to six months

Study Arms (2)

Standard Usual Care

OTHER

Community program which follows with referral services

Other: Standard Care

Prevention Awareness Groups (PAG)

EXPERIMENTAL

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)

Interventions

Prevention Awareness Groups (PAG)
Standard Usual Care

Eligibility Criteria

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

You may qualify if:

  • suburban, rural Population
  • Drug and/or alcohol dependency (DSM-IV substance use disorders criteria)

You may not qualify if:

  • Did not consent to participate
  • Planning to move or relocate
  • Severe mental disorder

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

GyanSanjeevani

Bai, Nawalgarh, Rajasthan, India

Location

MeSH Terms

Conditions

Substance-Related DisordersAlcoholism

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Chemically-Induced DisordersMental DisordersAlcohol-Related Disorders

Intervention Hierarchy (Ancestors)

Quality Indicators, Health CareQuality of Health CareHealth Services AdministrationHealth Care Quality, Access, and Evaluation

Study Officials

  • Valerie Murray, MA

    Goldington Family Centre

    STUDY DIRECTOR
  • Neha Sharma, PhD

    NMP Medical Research Institute

    PRINCIPAL INVESTIGATOR
  • Amit Punia, LLB

    NMP Medical Research Institute

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 22, 2014

First Posted

June 24, 2014

Study Start

August 1, 2014

Primary Completion

March 1, 2015

Study Completion

April 1, 2015

Last Updated

May 18, 2015

Record last verified: 2015-05

Locations