Drug AddictionNCT07161986
Mapping And Preventing Relapse Risk in Polydrug Users
A study testing Mindfullness based Sobriety (MBS) in people with Drug Addiction and Polysubstance Addiction, run by Institute of Psychology, Chinese Academy of Sciences at 1 site in Pakistan.
Trial summary
This Interventional two-arm comparative study will evaluate whether a mindfulness-based strategy (MBS) improves outcomes for adults with substance use disorders (polydrug users) compared with treatment-as-usual (TAU). Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Drug Addiction, Polysubstance Addiction
- What is being tested?
- Mindfullness based Sobriety (MBS)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 130 participants
- Where
- 1 sitePakistan
- Study dates
- 24 Jun 2025to 24 Aug 2025
- 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 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Individuals resided in Drug rehabilitations center with polysubstance use diagnosed particularly with illicit drug use.
- Age would be from 18 to 85 years
- Must include Patients after detox and withdrawal symptoms.
Who cannot join
- Individuals with any form of physical or intellectual disability will not be eligible to participate in the study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Mapping Relapse Risk and Evaluating an Integrated Approach for Preventing Relapse in Polydrug Users: A Randomized Control Trial
This Interventional two-arm comparative study will evaluate whether a mindfulness-based strategy (MBS) improves outcomes for adults with substance use disorders (polydrug users) compared with treatment-as-usual (TAU). The primary question is whether MBS lowers cravings and reduces relapse risk relative to TAU; secondary aims include improvements in emotion regulation, coping, depressive/anxiety symptoms, mindfulness, and motivation to change. The design includes two arms (MBS vs TAU) with baseline and post-intervention assessments; adherence within the MBS arm will also be examined (e.g., high- vs low-adherence) to test whether greater adherence yields better primary and secondary outcomes than TAU. Primary outcomes are craving and relapse risk; secondary outcomes are emotion regulation, coping, depressive and anxiety symptoms, mindfulness, and motivation to change. Hypotheses predict that MBS will reduce cravings and depressive/anxiety symptoms and improve mindfulness and emotion regulation as compared to TAU; that psychological network structure will differ by relapse-risk level and by adherence subgroup; and that motivation to change will mediate MBS effects.
Read the detailed description
This prospective observational, two-arm comparative study is to evaluate whether a mindfulness-based strategy (MBS) improves clinical and psychosocial outcomes and reduces relapse risk among adults with substance use disorders (polydrug users). The main question is whether long-term participation in MBS lowers cravings and reduces relapse risk compared with treatment-as-usual (TAU). The design includes two arms-an MBS arm (participants receiving the mindfulness-based strategy as part of care) and a TAU arm (participants receiving treatment as usual)-with adherence to MBS also analyzed (e.g., high- vs low-adherence subgroups). Participants will be adults with SUDs/polydrug use; the target sample size is 130 Participants with MBS (n=60) and TAU (n=70). Baseline and post-intervention assessments were conducted, using measures culturally adapted to Urdu. The objectives are to test whether MBS reduces substance cravings and relapse risk relative to TAU; assess improvements in emotion regulation, coping, mindfulness, depression, anxiety, and motivation to change; examine how adherence to MBS relates to outcomes; and use network analysis to characterize connections among psychological variables and compare structures by relapse risk, adherence level. The hypotheses are: H1 (Primary/Secondary): MBS will reduce cravings and Relapse Risk (primary) and depressive/anxiety symptoms, improve mindfulness, motivation to Change and emotion regulation (secondary). H2 (Primary/Secondary): Higher MBS adherence will yield better primary (Reduce craving, relapse risk) and secondary outcomes than TAU. H3: Network density/connectivity among psychological variables will differ by relapse-risk level within MBS. H4: Post-test network structures will differ between high- vs low-adherence MBS participants. H5: The Study 2 network will show weaker links between relapse factors and symptoms than Study 1, reflecting MBS impact. H6: MBS will improve coping skills, emotion regulation, and mindfulness. H7: Motivation to change will mediate the relationship between MBS participation and outcomes. Primary outcomes are craving and relapse risk (Relapse Risk Scale; subscales: compulsivity to use, abstinence-violation effect, anxiety problems, low self-efficacy). Secondary outcomes include emotion regulation (CERQ: self-blame, acceptance, rumination, positive refocusing, planning, positive reappraisal, putting into perspective, catastrophizing, other-blame), mindfulness (MAAS; note that higher scores indicate lower mindfulness ), depression, anxiety, and stress (DASS-21), coping (Brief COPE Urdu: emotion-focused, avoidance-focused, problem-focused), and motivation to change (RCQ: precontemplation, contemplation, action). Analytically, group comparisons will contrast MBS versus TAU on primary and secondary outcomes with stratification by MBS adherence; network analysis will compare network density and structure across relapse-risk strata, adherence subgroups, and between Study 2 and Study 1; and mediation models will test whether motivation to change mediates MBS effects on outcomes.
- Conditions
- Drug Addiction, Polysubstance Addiction
- Being tested
- Mindfullness based Sobriety (MBS)
- Keywords
- Illicit Drug use, Relpase Prevention, Mindfullness intervention
- Medical subject headings
- Substance-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mindfullness based Sobriety (MBS)Behavioural
MBS is combination of Mindfullness , Relapse prevention, motivational interviewing , acceptance and commitment therapy. It helps in dealing underlying depression and anxiety issues among Polysubstance use. it Cover most of underlying problem faced by person with addiction.
| Study group | Role | What they receive |
|---|---|---|
| Mindfullness Based Intervention | Active comparator | Mindfullness based intervention arm is taking intervention which is based on Mindfullness based sobriety manaual for Relpase prevention and craving as primary outcome Receives: Behavioral: Mindfullness based Sobriety (MBS) |
| Treatment As Usual | No intervention | Treatment as usual group would take tradational treatment at rehablitataion center not particular intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Relpase Risk
Relapse Risk Relapse risk will be measured using the Relapse Risk Scale, consisting of four subscales: compulsivity to use, abstinence violation effect, anxiety problems, and low self-efficacy. Scores classify risk as: High (>170), Moderate (98-170), or Low (<98).
Measured: From Enrollment to end of treatment at 6 weeks and then 2 week followup
Craving
Craving Craving will be measured using a rating scale from 1 (minimum) to 10 (maximum), with higher scores indicating greater craving intensity.
Measured: From Enrollment to end of treatment at 6 weeks and then 2 week followup
Secondary outcomes (4)
Emotional Regulation Skills
Measured using the Cognitive Emotion Regulation Questionnaire (Shahzad et al., 2022). Subscales include self-blame, acceptance, rumination, positive refocusing, planning, reappraisal, perspective, catastrophizing, and other-blame. Each subscale ranges from 4-20; total score ranges from 36-180. Higher scores indicate greater use of that strategy.
Measured: From Enrollment to the end of treatment at 6 week and 2 week followup
mental Health Conditions
mental health condition such as Depression, Anxiety, and Stress will be measured using the DASS-21 (Aslam \& Kamal, 2017). Scores range: Depression (0-4), Anxiety (0-3), Stress (0-7). Higher scores reflect greater symptom severity
Measured: From Enrollment to the end of treatment at 6 week and 2 week followup
Mindfulness (MAAS)
Mindfulness Attention Awareness Scale (Bakhteyar et al., 2021). Higher scores (closer to 6) indicate higher levels of mindfulness.
Measured: From Enrollment to the end of treatment at 6 week and 2 week followup
Motivation to Change (RCQ)
Measured via Readiness to Change Questionnaire (Mubashir et al., 2025). Subscales: Precontemplation, Contemplation, Action. Subscale scores are calculated by summing the respective item scores and high scores indicate strong identification with that specific stage of change.
Measured: From Enrollment to the end of treatment at 6 week and 2 week followup
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2025
- Study start24 Jun 2025
- Primary completion15 Jul 2025
- Study completion24 Aug 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Drug AddictionStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The study consist of two groups, one is taking mindfullness intervention and other is Treatment as Usual
- Masking
- None (open label)
- Enrolment
- 130 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institute of Psychology, Chinese Academy of Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Li Yonghui Professor, Institute Of Psychology,Chinese Acedmy of Sciences, Study chair, Institute Of Psychology,Chinese Acedmy of SciencesRomana Younas PhD fellow, Mphil ClPsy, Principal investigator, Institute of Psychology,Chinese Acedmy Of SciencesSalman Shahzad Professor, Study director, Institute of Clinical Psychology,Universitry of Karachi,Pakistan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07161986
- Sponsor's protocol ID
- H24149
- Other IDs
- 2021ZD0202104
- Status last verified
- Jun 2025
- First submitted
- 24 Aug 2025
- Last updated
- 9 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: As clients are not agreed to share thier data with other party , beacsue data is confidential and bound to follow ethical consideration and regulations.
Publications
Priddy SE, Howard MO, Hanley AW, Riquino MR, Friberg-Felsted K, Garland EL. Mindfulness meditation in the treatment of substance use disorders and preventing future relapse: neurocognitive mechanisms and clinical implications. Subst Abuse Rehabil. 2018 Nov 16;9:103-114. doi: 10.2147/SAR.S145201. eCollection 2018.
PubMed 30532612
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mapping Relapse Risk and Evaluating an Integrated Approach for Preventing Relapse in Polydrug Users: A Randomized Control Trial
- ClinicalTrials.gov ID
- NCT07161986
- Acronym / sponsor ID
- H24149
- Conditions
- Drug Addiction, Polysubstance Addiction
- Keywords
- Illicit Drug use, Relpase Prevention, Mindfullness intervention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 130 participants (actual)
- Lead sponsor
- Institute of Psychology, Chinese Academy of SciencesUniversity, hospital or other
- Study start
- 24 Jun 2025 (actual)
- Primary completion
- 15 Jul 2025 (actual)
- Study completion
- 24 Aug 2025 (actual)
- First posted
- 9 Sep 2025 (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.
This Interventional two-arm comparative study will evaluate whether a mindfulness-based strategy (MBS) improves outcomes for adults with substance use disorders (polydrug users) compared with treatment-as-usual (TAU). The primary question is whether MBS lowers cravings and reduces relapse risk relative to TAU; secondary aims include improvements in emotion regulation, coping, depressive/anxiety symptoms, mindfulness, and motivation to change. The design includes two arms (MBS vs TAU) with baseline and post-intervention assessments; adherence within the MBS arm will also be examined (e.g., high- vs low-adherence) to test whether greater adherence yields better primary and secondary outcomes than TAU. Primary outcomes are craving and relapse risk; secondary outcomes are emotion regulation, coping, depressive and anxiety symptoms, mindfulness, and motivation to change. Hypotheses predict that MBS will reduce cravings and depressive/anxiety symptoms and improve mindfulness and emotion regulation as compared to TAU; that psychological network structure will differ by relapse-risk level and by adherence subgroup; and that motivation to change will mediate MBS effects.
Detailed description
This prospective observational, two-arm comparative study is to evaluate whether a mindfulness-based strategy (MBS) improves clinical and psychosocial outcomes and reduces relapse risk among adults with substance use disorders (polydrug users). The main question is whether long-term participation in MBS lowers cravings and reduces relapse risk compared with treatment-as-usual (TAU). The design includes two arms-an MBS arm (participants receiving the mindfulness-based strategy as part of care) and a TAU arm (participants receiving treatment as usual)-with adherence to MBS also analyzed (e.g., high- vs low-adherence subgroups). Participants will be adults with SUDs/polydrug use; the target sample size is 130 Participants with MBS (n=60) and TAU (n=70). Baseline and post-intervention assessments were conducted, using measures culturally adapted to Urdu. The objectives are to test whether MBS reduces substance cravings and relapse risk relative to TAU; assess improvements in emotion regulation, coping, mindfulness, depression, anxiety, and motivation to change; examine how adherence to MBS relates to outcomes; and use network analysis to characterize connections among psychological variables and compare structures by relapse risk, adherence level. The hypotheses are: H1 (Primary/Secondary): MBS will reduce cravings and Relapse Risk (primary) and depressive/anxiety symptoms, improve mindfulness, motivation to Change and emotion regulation (secondary). H2 (Primary/Secondary): Higher MBS adherence will yield better primary (Reduce craving, relapse risk) and secondary outcomes than TAU. H3: Network density/connectivity among psychological variables will differ by relapse-risk level within MBS. H4: Post-test network structures will differ between high- vs low-adherence MBS participants. H5: The Study 2 network will show weaker links between relapse factors and symptoms than Study 1, reflecting MBS impact. H6: MBS will improve coping skills, emotion regulation, and mindfulness. H7: Motivation to change will mediate the relationship between MBS participation and outcomes. Primary outcomes are craving and relapse risk (Relapse Risk Scale; subscales: compulsivity to use, abstinence-violation effect, anxiety problems, low self-efficacy). Secondary outcomes include emotion regulation (CERQ: self-blame, acceptance, rumination, positive refocusing, planning, positive reappraisal, putting into perspective, catastrophizing, other-blame), mindfulness (MAAS; note that higher scores indicate lower mindfulness ), depression, anxiety, and stress (DASS-21), coping (Brief COPE Urdu: emotion-focused, avoidance-focused, problem-focused), and motivation to change (RCQ: precontemplation, contemplation, action). Analytically, group comparisons will contrast MBS versus TAU on primary and secondary outcomes with stratification by MBS adherence; network analysis will compare network density and structure across relapse-risk strata, adherence subgroups, and between Study 2 and Study 1; and mediation models will test whether motivation to change mediates MBS effects on outcomes.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The study consist of two groups, one is taking mindfullness intervention and other is Treatment as Usual
| Arm | Type | Receives |
|---|---|---|
| Mindfullness Based Intervention | Active comparator | Behavioral: Mindfullness based Sobriety (MBS)Mindfullness based intervention arm is taking intervention which is based on Mindfullness based sobriety manaual for Relpase prevention and craving as primary outcome |
| Treatment As Usual | No intervention | –Treatment as usual group would take tradational treatment at rehablitataion center not particular intervention |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Individuals resided in Drug rehabilitations center with polysubstance use diagnosed particularly with illicit drug use.
- Age would be from 18 to 85 years
- Must include Patients after detox and withdrawal symptoms.
Key exclusion criteria (1 listed)
- Individuals with any form of physical or intellectual disability will not be eligible to participate in the study
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 |
|---|---|---|
| Mindfullness based Sobriety (MBS)MBS is combination of Mindfullness , Relapse prevention, motivational interviewing , acceptance and commitment therapy. It helps in dealing underlying depression and anxiety issues among Polysubstance use. it Cover most of underlying problem faced by person with addiction. | Behavioural | Mindfullness Based Intervention |
Primary outcome
Relpase Risk
Time frame: From Enrollment to end of treatment at 6 weeks and then 2 week followup
Relapse Risk Relapse risk will be measured using the Relapse Risk Scale, consisting of four subscales: compulsivity to use, abstinence violation effect, anxiety problems, and low self-efficacy. Scores classify risk as: High (>170), Moderate (98-170), or Low (<98).
Craving
Time frame: From Enrollment to end of treatment at 6 weeks and then 2 week followup
Craving Craving will be measured using a rating scale from 1 (minimum) to 10 (maximum), with higher scores indicating greater craving intensity.
4 secondary outcomes
Emotional Regulation Skills
Time frame: From Enrollment to the end of treatment at 6 week and 2 week followup
mental Health Conditions
Time frame: From Enrollment to the end of treatment at 6 week and 2 week followup
Mindfulness (MAAS)
Time frame: From Enrollment to the end of treatment at 6 week and 2 week followup
Motivation to Change (RCQ)
Time frame: From Enrollment to the end of treatment at 6 week and 2 week followup
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 9 Sep 2025.
- Results publication: PubMed 30532612Priddy SE, Howard MO, Hanley AW, Riquino MR, Friberg-Felsted K, Garland EL. Mindfulness meditation in the treatment of substance use disorders and preventing future relapse: neurocognitive mechanisms and clinical implications. Subst Abuse Rehabil. 2018 Nov 16;9:103-114. doi: 10.2147/SAR.S145201. eCollection 2018.
- Individual participant dataSharing planned: No. As clients are not agreed to share thier data with other party , beacsue data is confidential and bound to follow ethical consideration and regulations.
Related trials for Drug Addiction
RecruitingObservational study
Outcome Inference in the Sensory Preconditioning Task in Opioid-Use Disorder
Opioid-Related Disorders, Drug Addiction
Recruiting
Fighting Addictions, Improving Lives: COmprehensive Drug Rehabilitation With Music
Substance Use Disorder (SUD)
Active, not recruiting
The MOUD Plus Pilot: Counseling and Peer Support to Support Retention for Medically Complex Patients With Opioid Use Disorder Seen In Primary Care
Opioid Dependence, Substance Abuse Disorders
Active, not recruiting
Supporting Treatment Access and Recovery Through Linkage and Support
Mental Health Disorders, Substance Use Disorders
Not yet recruitingPhase 1/2
Medically Supervised Ibogaine With 12-Month Digital Recovery Support for Opioid Use Disorder
Opioid Use Disorder, Opioid Withdrawal
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.
Li Yonghui Professor, Institute Of Psychology,Chinese Acedmy of Sciences study chair
Institute Of Psychology,Chinese Acedmy of Sciences
Romana Younas PhD fellow, Mphil ClPsy principal investigator
Institute of Psychology,Chinese Acedmy Of Sciences
Salman Shahzad Professor study director
Institute of Clinical Psychology,Universitry of Karachi,Pakistan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mindfullness based Sobriety (MBS) in people with Drug Addiction and Polysubstance Addiction, run by Institute of Psychology, Chinese Academy of Sciences 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 3 inclusion and 1 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 9 Sep 2025. 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?
Relpase Risk (time frame: From Enrollment to end of treatment at 6 weeks and then 2 week followup). The study lists 2 primary outcomes in all. 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 NCT07161986, which also lists 1 linked publication.
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 9 Sep 2025.