Mapping And Preventing Relapse Risk in Polydrug Users

NCT07161986 | Completed

• 2 other identifiers: H241492021ZD0202104
• Study Type: interventional
• Target: 130
• Locations: 1 country
• Sites: 1

Brief 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). 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.

Conditions

Drug Addiction; Polysubstance Addiction

Keywords

Illicit Drug use; Relpase Prevention; Mindfullness intervention

Outcome Measures

Primary Outcomes (2)

• 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

Secondary Outcomes (4)

• 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

Other Outcomes (1)

• Coping Skills

  From Enrollment to end of treatment at 6 weeks and then 2 week followup

Study Arms (2)

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

Behavioral: Mindfullness based Sobriety (MBS)

Treatment As Usual

NO INTERVENTION

Treatment as usual group would take tradational treatment at rehablitataion center not particular intervention

Interventions

Mindfullness based Sobriety (MBS) BEHAVIORAL

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.

Mindfullness Based Intervention

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Individuals with any form of physical or intellectual disability will not be eligible to participate in the study

Sponsors & Collaborators

• Institute of Psychology, Chinese Academy of Sciences: lead

Study Sites (1)

Save Life Foundation

Abbottābād, Khyber Pakhtunkhwa, Pakistan

Location

Related Publications (1)

• 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.

  PMID: 30532612 BACKGROUND

MeSH Terms

Conditions

Substance-Related Disorders

Condition Hierarchy (Ancestors)

Chemically-Induced Disorders; Mental Disorders

Study Officials

• Li Yonghui Professor, Institute Of Psychology,Chinese Acedmy of Sciences

  Institute Of Psychology,Chinese Acedmy of Sciences

  STUDY CHAIR

• Romana Younas PhD fellow, Mphil ClPsy

  Institute of Psychology,Chinese Acedmy Of Sciences

  PRINCIPAL INVESTIGATOR

• Salman Shahzad Professor

  Institute of Clinical Psychology,Universitry of Karachi,Pakistan

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: The study consist of two groups, one is taking mindfullness intervention and other is Treatment as Usual

Study Record Dates

• First Submitted: August 24, 2025
• First Posted: September 9, 2025
• Study Start: June 24, 2025
• Primary Completion: July 15, 2025
• Study Completion: August 24, 2025
• Last Updated: September 9, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)