--- title: Adapted RPM-08 for Substance Use Disorder in Pakistan nct_id: NCT07552623 overall_status: COMPLETED phase: NA sponsor: Universiti Sains Malaysia study_type: INTERVENTIONAL primary_condition: Substance Use Disorder (SUD) countries: Pakistan canonical_url: "https://parkinsonspathways.com/agent/trials/NCT07552623.md" clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT07552623" ct_last_update_post_date: 2026-04-27 last_seen_at: "2026-05-12T06:57:26.385Z" source: ClinicalTrials.gov (mirrored, no enrichment) --- # Adapted RPM-08 for Substance Use Disorder in Pakistan **Official Title:** Effect of Adapted Relapse Prevention Module (RPM-08) for Patients With Substance Use Disorder in Pakistan **NCT ID:** [NCT07552623](https://clinicaltrials.gov/study/NCT07552623) ## Key Facts - **Status:** COMPLETED - **Phase:** NA - **Study Type:** INTERVENTIONAL - **Target Enrollment:** 70 - **Lead Sponsor:** Universiti Sains Malaysia - **Conditions:** Substance Use Disorder (SUD), Drug Abuse, Relapse - **Start Date:** 2024-01-04 - **Completion Date:** 2024-04-13 - **CT.gov Last Update:** 2026-04-27 ## Brief Summary The goal of this clinical trial is to learn if a culturally adapted Relapse Prevention Module (RPM-08) can reduce relapse risk in people with substance use disorders in Pakistan. The study also examines whether the adapted intervention is effective over time. The main questions it aims to answer are: Does the adapted RPM-08 reduce relapse risk compared to usual treatment? Are the effects of the intervention maintained after a follow-up period? Researchers compared participants who received the adapted RPM-08 along with usual treatment to those who received usual treatment only to see if the intervention improves relapse outcomes. Participants will: Attend eight structured group sessions over eight weeks Receive usual treatment provided by the rehabilitation center Complete questionnaires at baseline, after the intervention, and at follow-up ## Detailed Description This study employed a sequential exploratory mixed-method design integrating qualitative and quantitative phases. The qualitative phase focused on the cultural adaptation of the Relapse Prevention Module (RPM-08) using the ADAPT-ITT framework and Bernal's Ecological Validity Model to ensure cultural and contextual appropriateness for individuals with substance use disorders in Pakistan. The adaptation process involved expert consultation, iterative refinement, forward-backward translation procedures, and pilot testing to establish linguistic clarity, cultural relevance, and clinical applicability of the intervention. The quantitative phase utilized a non-randomized two-group pretest-posttest quasi-experimental design with a follow-up component. Participants were recruited using purposive sampling from a residential rehabilitation setting in Punjab, Pakistan. Eligible participants included male individuals diagnosed with moderate substance use disorder who were clinically stable and able to participate in group-based intervention sessions. Participants were allocated into experimental and control groups within the treatment setting. The experimental group received the adapted RPM-08 intervention in addition to Treatment-As-Usual (TAU), while the control group received TAU only. TAU consisted of standard rehabilitation services including medical care, counselling, and psychosocial support. The adapted intervention was delivered as a structured group-based program consisting of eight sessions based on cognitive-behavioral relapse prevention principles. The sessions focused on relapse awareness, coping strategies, identification of high-risk situations, and development of relapse prevention plans, with culturally relevant modifications incorporated into content and delivery. Data were collected at multiple time points to examine changes over time and differences between groups. Statistical analyses were conducted using appropriate non-parametric tests and covariance-based methods to evaluate intervention effects while accounting for baseline differences and relevant covariates. This study was registered retrospectively after completion of data collection. ## Eligibility - **Minimum age:** 17 Years - **Maximum age:** 56 Years - **Sex:** MALE - **Healthy Volunteers:** No ``` Inclusion Criteria: * Male participants diagnosed with moderate substance use disorder (DSM-5-TR) * Aged 17 to 56 years * Currently enrolled in a residential rehabilitation program * Medically and psychologically stable to participate in group sessions * Able to provide informed consent Exclusion Criteria: * Individuals diagnosed with severe psychiatric disorders (e.g., bipolar disorder, psychotic depression) * Individuals with cognitive impairments affecting participation * Individuals currently undergoing detoxification or taking medications that may influence treatment outcomes ``` ## Arms - **RPM-08 + Treatment-As-Usual** (EXPERIMENTAL) — Participants in this arm received the adapted Relapse Prevention Module (RPM-08) in addition to Treatment-As-Usual (TAU). The intervention consisted of eight structured group sessions delivered over eight weeks, focusing on relapse prevention strategies, coping skills, and management of high-risk situations. - **Treatment-As-Usual** (ACTIVE_COMPARATOR) — Participants in this arm received Treatment-As-Usual (TAU), which included standard rehabilitation services such as medical care, counselling, and psychosocial support provided by the treatment facility. ## Interventions - **Adapted Relapse Prevention Module (RPM-08)** (BEHAVIORAL) — The adapted Relapse Prevention Module (RPM-08) is a structured cognitive-behavioral intervention designed to reduce relapse risk among individuals with substance use disorders. It is based on relapse prevention principles and the stages of change model, focusing on identifying high-risk situations, recognizing early warning signs, and developing coping strategies. The intervention was culturally adapted for the Pakistani context and delivered in a group format. It consisted of eight structured sessions conducted over eight weeks. The sessions included psychoeducation, cognitive restructuring, emotional regulation, coping skills training, and relapse prevention planning. Cultural adaptations incorporated locally relevant examples, family-oriented perspectives, and context-specific coping strategies to enhance engagement and applicability. - **Treatment as Usual (TAU)** (OTHER) — Standard rehabilitation care provided by the treatment facility, including medical monitoring, counselling sessions, and psychosocial support services. ## Primary Outcomes - **Relapse Risk** _(time frame: Baseline, post-intervention (8 weeks), and 45-day follow-up)_ — Relapse risk was assessed using the Advance Warning of Relapse (AWARE) questionnaire to evaluate changes in relapse-related warning signs among participants across different assessment time points. ## Secondary Outcomes - **Change in Relapse Risk Over Time** _(time frame: Baseline, post-intervention (8 weeks), and 45-day follow-up)_ ## Locations (1) - Ghamkol Decent Rehab Center Addiction Treatment Center Lahore, Lahore, Punjab Province, Pakistan ## Recent Field Changes (last 30 days) - `status.overallStatus` — added _(2026-05-12)_ - `status.primaryCompletionDate` — added _(2026-05-12)_ - `status.completionDate` — added _(2026-05-12)_ - `status.lastUpdatePostDate` — added _(2026-05-12)_ - `design.phases` — added _(2026-05-12)_ - `design.enrollmentCount` — added _(2026-05-12)_ - `eligibility.criteria` — added _(2026-05-12)_ - `eligibility.minAge` — added _(2026-05-12)_ - `eligibility.maxAge` — added _(2026-05-12)_ - `eligibility.sex` — added _(2026-05-12)_ - `outcomes.primary` — added _(2026-05-12)_ - `outcomes.secondary` — added _(2026-05-12)_ - `armsInterventions.arms` — added _(2026-05-12)_ - `armsInterventions.interventions` — added _(2026-05-12)_ - `sponsor.lead` — added _(2026-05-12)_ - `results.hasResults` — added _(2026-05-12)_ - `locations.ghamkol decent rehab center addiction treatment center lahore|lahore|punjab province|pakistan` — added _(2026-05-12)_ --- *Canonical: https://parkinsonspathways.com/agent/trials/NCT07552623.md* *Source data (authoritative): https://clinicaltrials.gov/study/NCT07552623* *This page is a raw mirror with no AI summary, no editorial enrichment, and no Parkinson's-specific filtering.*