NCT07161986|Completed
Mapping And Preventing Relapse Risk in Polydrug Users
Mapping Relapse Risk and Evaluating an Integrated Approach for Preventing Relapse in Polydrug Users: A Randomized Control Trial
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Mapping Relapse Risk and Evaluating an Integrated Approach for Preventing Relapse in Polydrug Users: A Randomized Control Trial
Sponsor study identifier
Secondary identifiers
OTHER_GRANT · Center for Excellence in Brain Science and Intelligence Technology
interventional
130
1 country
1
Study Start
June 24, 2025
Actual (reported)Primary Completion
July 15, 2025
Actual (reported)Study Completion
August 24, 2025
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
August 24, 2025
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
June 24, 2025
Actual (reported)July 15, 2025
Actual (reported)August 24, 2025
Actual (reported)August 24, 2025
Actual (reported)September 9, 2025
Actual (reported)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).
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.
From Enrollment to end of treatment at 6 weeks and then 2 week followup
Emotional Regulation Skills
From Enrollment to the end of treatment at 6 week and 2 week followup
mental Health Conditions
From Enrollment to the end of treatment at 6 week and 2 week followup
Mindfulness (MAAS)
From Enrollment to the end of treatment at 6 week and 2 week followup
Motivation to Change (RCQ)
From Enrollment to the end of treatment at 6 week and 2 week followup
Coping Skills
From Enrollment to end of treatment at 6 weeks and then 2 week followup
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 group would take tradational treatment at rehablitataion center not particular intervention
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.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Save Life Foundation
Abbottābād, Khyber Pakhtunkhwa, Pakistan
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.
Li Yonghui Professor, Institute Of Psychology,Chinese Acedmy of Sciences
Institute Of Psychology,Chinese Acedmy of Sciences
Romana Younas PhD fellow, Mphil ClPsy
Institute of Psychology,Chinese Acedmy Of Sciences
Salman Shahzad Professor
Institute of Clinical Psychology,Universitry of Karachi,Pakistan
130 participants (actual enrollment reported by the registry).
First Submitted
August 24, 2025
First Posted
September 9, 2025
Study Start
June 24, 2025
Actual (reported)Contact the study team to confirm eligibility.
Primary Completion
July 15, 2025
Actual (reported)Study Completion
August 24, 2025
Actual (reported)Last Updated
September 9, 2025
Record last verified: 2025-06
As clients are not agreed to share thier data with other party , beacsue data is confidential and bound to follow ethical consideration and regulations.
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Source: ClinicalTrials.gov.
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