NCT06559631

Brief Summary

Central idea of the study is to adapt a treatment program for drug addiction treatment indigenously and relapse prevention, and to establish its efficacy. This study helps the society to have an evidence-based approach with proven efficacy to deal with drugs related issues in Pakistan along with minimizing the rate of relapse which is the major issue with current disease model for treatment of addiction in different rehabs within the country. Present study's aim is to adapt culturally and islamically a robust treatment protocol: Reinforcement Approach (CRA) through randomized control trial to determine its efficacy in the field of drug addiction rehabilitation. Moreover, CRA is also be used with comorbid psychological illnesses. Because, in the treatment facilities disease model is currently prevailing which lacks empirical evidence, and they do not have proven efficacy.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
59

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2022

Geographic Reach
1 country

2 active sites

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

Study Start

First participant enrolled

February 4, 2022

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 25, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 25, 2023

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

January 31, 2024

Completed
7 months until next milestone

First Posted

Study publicly available on registry

August 19, 2024

Completed
Last Updated

August 19, 2024

Status Verified

August 1, 2024

Enrollment Period

1.5 years

First QC Date

January 31, 2024

Last Update Submit

August 14, 2024

Conditions

Keywords

Substance Use DisordersTreatment ModelComorbid Mental DisordersResidential Treatment

Outcome Measures

Primary Outcomes (1)

  • Recovery

    Staying in abstinence from the drug of abuse. Recovery will be measured through Addiction Recovery Questionnaire (ARQ), this is a 4 point rating scale which measures normal living, abstinence and positive expectancy as recovery's subscales.

    First assessment will be conducted at the time of admission which will be completed till 21 days after admission. Second assessment after 120 days at the time of discharge. Third outcome measure during the follow up at the sixth month after discharge.

Secondary Outcomes (1)

  • Comorbidities

    First assessment will be conducted at the time of admission which will be completed till 21 days after admission. Second assessment after 120 days at the time of discharge. Third outcome measure during the follow up at the sixth month after discharge.

Study Arms (2)

Treatment Group

EXPERIMENTAL

Experimental group will receive the indigenously adapted Community Reinforcement Approach based psychotherapeutic sessions after the completion of drugs related detoxification (after 21 days since hospitalization) for 90-120 days in residential treatment.

Behavioral: Indigenously Adapted CRA

Control Group: Treatment as usual

NO INTERVENTION

This group will receive treatment as usual which includes detoxification of drugs, general counselling for drug addiction prevention, 12 steps program and life skills training. Duration of residential treatment is between 90-120 days.

Interventions

Treatment group will receive psychotherapy based on CRA which is an evidence based approach. This adapted version of CRA also consists emotional management, behavioral interventions, drug addiction treatment and islamically integrated psychotherapy for drug addiction and comorbid mental disorders.

Treatment Group

Eligibility Criteria

Age16 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Patient admitted for treatment of drug addiction with or without comorbid psychological disorders.

You may not qualify if:

  • Patient with no history of drug abuse.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Hayat Rehab Clinic (HRC)

Islamabad, 46500, Pakistan

Location

Islamabad Rehab Clinic (IRC)

Islamabad, 46500, Pakistan

Location

Related Links

MeSH Terms

Conditions

Substance-Related Disorders

Condition Hierarchy (Ancestors)

Chemically-Induced DisordersMental Disorders

Study Officials

  • Dr. Mazhar Iqbal Bhatti

    International Islamic University, Islamabad

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Masking Details
single-blind randomized controlled trial (RCT)
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Research design of the study shall consists two-arms, single-blind randomized controlled trial (RCT). While Randomized Control Trial (RCT) shall consists of two groups: Active Treatment (AT) group and Control group
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Director of clinical affaires, Clinical Psychologist, Principal Investigator, at Islamabad Rehab Clinic.

Study Record Dates

First Submitted

January 31, 2024

First Posted

August 19, 2024

Study Start

February 4, 2022

Primary Completion

July 25, 2023

Study Completion

July 25, 2023

Last Updated

August 19, 2024

Record last verified: 2024-08

Data Sharing

IPD Sharing
Will share
Shared Documents
STUDY PROTOCOL, ICF, CSR

Locations