Substance Use Disorder (SUD)NCT07552623
Adapted RPM-08 for Substance Use Disorder in Pakistan
A study testing Adapted Relapse Prevention Module (RPM-08) and Treatment as Usual (TAU) in people with Substance Use Disorder (SUD) and Drug Abuse, run by Universiti Sains Malaysia at 1 site in Pakistan.
Trial 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. Read more about this study
- Who is it for?
- Ages 17 to 56 years, men only
- Conditions the study is for
- Substance Use Disorder (SUD), Drug Abuse, Relapse
- What is being tested?
- Adapted Relapse Prevention Module (RPM-08) and Treatment as Usual (TAU)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 sitePakistan
- Study dates
- 4 Jan 2024to 13 Apr 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 17 to 56 years
- Men only
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Pakistan1 site
Ghamkol Decent Rehab Center Addiction Treatment Center Lahore
Lahore, Punjab Province, 54000
About this study
Official title: Effect of Adapted Relapse Prevention Module (RPM-08) for Patients With Substance Use Disorder in Pakistan
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:
Read more
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
Read the 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.
- Conditions
- Substance Use Disorder (SUD), Drug Abuse, Relapse
- Being tested
- Adapted Relapse Prevention Module (RPM-08), Treatment as Usual (TAU)
- Keywords
- Relapse Prevention, Cognitive Behavioral Therapy, Substance Use Disorder, Rehabilitation, Quasi-Experimental Study, Pakistan, Addiction Treatment, RPM-08
- Medical subject headings
- Substance-Related Disorders, Recurrence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Adapted Relapse Prevention Module (RPM-08)Behavioural
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.
Standard rehabilitation care provided by the treatment facility, including medical monitoring, counselling sessions, and psychosocial support services.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Adapted Relapse Prevention Module (RPM-08) |
| 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. Receives: Other: Treatment as Usual (TAU) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Relapse Risk
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.
Measured: Baseline, post-intervention (8 weeks), and 45-day follow-up
Secondary outcomes (1)
Change in Relapse Risk Over Time
Changes in relapse risk scores measured using the Advance Warning of Relapse (AWARE) questionnaire across baseline, post-intervention, and follow-up assessments to evaluate differences over time and between study groups.
Measured: Baseline, post-intervention (8 weeks), and 45-day follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2026
- Study start4 Jan 2024
- Primary completion28 Feb 2024
- Study completion13 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Substance Use Disorder (SUD)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- This study used a non-randomized parallel group design with two arms. Participants were allocated into an experimental group receiving the adapted RPM-08 intervention in addition to Treatment-As-Usual (TAU) and a control group receiving TAU only. Both groups were assessed at baseline, post-intervention, and follow-up to evaluate changes over time.
- Masking
- None (open label)
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universiti Sains Malaysia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rabab Zahra, Universiti Sains Malaysia
- Investigators
- Rabab Zahra, PhD Candidate (Psychology), Principal investigator, Universiti Utara Malaysia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07552623
- Sponsor's protocol ID
- RPM-08-UMP-2024
- Status last verified
- Apr 2026
- First submitted
- 20 Apr 2026
- Last updated
- 27 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared due to confidentiality and ethical considerations related to sensitive patient information. Data may be available from the principal investigator upon reasonable request for academic purposes.
Publications
Prochaska JO, DiClemente CC. Stages and processes of self-change of smoking: toward an integrative model of change. J Consult Clin Psychol. 1983 Jun;51(3):390-5. doi: 10.1037//0022-006x.51.3.390. No abstract available.
PubMed 6863699Marlatt GA, Gordon JR. Relapse Prevention: Maintenance Strategies in the Treatment of Addictive Behaviors. New York: Guilford Press; 1985.
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Adapted Relapse Prevention Module (RPM-08) for Patients With Substance Use Disorder in Pakistan
- ClinicalTrials.gov ID
- NCT07552623
- Acronym / sponsor ID
- RPM-08-UMP-2024
- Conditions
- Substance Use Disorder (SUD), Drug Abuse, Relapse
- Keywords
- Relapse Prevention, Cognitive Behavioral Therapy, Substance Use Disorder, Rehabilitation, Quasi-Experimental Study, Pakistan, Addiction Treatment, RPM-08
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Universiti Sains MalaysiaUniversity, hospital or other
- Study start
- 4 Jan 2024 (actual)
- Primary completion
- 28 Feb 2024 (actual)
- Study completion
- 13 Apr 2024 (actual)
- First posted
- 27 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This study used a non-randomized parallel group design with two arms. Participants were allocated into an experimental group receiving the adapted RPM-08 intervention in addition to Treatment-As-Usual (TAU) and a control group receiving TAU only. Both groups were assessed at baseline, post-intervention, and follow-up to evaluate changes over time.
| Arm | Type | Receives |
|---|---|---|
| RPM-08 + Treatment-As-Usual | Experimental | Behavioral: Adapted Relapse Prevention Module (RPM-08)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 | Other: Treatment as Usual (TAU)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. |
Who may qualify
- Ages
- 17 to 56 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Adapted Relapse Prevention Module (RPM-08)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. | Behavioural | RPM-08 + Treatment-As-Usual |
| Treatment as Usual (TAU)Standard rehabilitation care provided by the treatment facility, including medical monitoring, counselling sessions, and psychosocial support services. | Other | Treatment-As-Usual |
Primary outcome
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.
1 secondary outcome
Change in Relapse Risk Over Time
Time frame: Baseline, post-intervention (8 weeks), and 45-day follow-up
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2026.
- Background: PubMed 6863699Prochaska JO, DiClemente CC. Stages and processes of self-change of smoking: toward an integrative model of change. J Consult Clin Psychol. 1983 Jun;51(3):390-5. doi: 10.1037//0022-006x.51.3.390. No abstract available.
- BackgroundMarlatt GA, Gordon JR. Relapse Prevention: Maintenance Strategies in the Treatment of Addictive Behaviors. New York: Guilford Press; 1985.
- Individual participant dataSharing planned: No. Individual participant data will not be shared due to confidentiality and ethical considerations related to sensitive patient information. Data may be available from the principal investigator upon reasonable request for academic purposes.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rabab Zahra, PhD Candidate (Psychology) principal investigator
Universiti Utara Malaysia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Adapted Relapse Prevention Module (RPM-08) and Treatment as Usual (TAU) in people with Substance Use Disorder (SUD) and Drug Abuse, run by Universiti Sains Malaysia at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Relapse Risk (time frame: Baseline, post-intervention (8 weeks), and 45-day follow-up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07552623, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Apr 2026.