Substance Use DisorderNCT06739304

The Effectiveness of Mindfulness-based Relapse Prevention

A study testing Mindfulness-based Relapse Prevention in people with Substance Use Disorder, run by Sir Run Run Shaw Hospital at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 25 to 57 years, women onlyHealthy volunteers can take part
Conditions the study is for: Substance Use Disorder
What is being tested?: Mindfulness-based Relapse Prevention
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 1,200 participants
Where: 1 siteChina
Study dates: 10 Jun 2023to 10 Nov 2023
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 25 to 57 years
Women only
Healthy volunteers accepted
Adult

Who may be able to join

Meets the diagnostic criteria for DSM-5 of substance use disorders;
The duration of using the addictive substance shall not be less than 1 year;
Prohibit addictive substances for at least 48 hours before conducting magnetic resonance imaging scans;
Han nationality, junior high school or above education level, aged 18-57 years old;
Informed and agreed to participate in this study, with the consent of the Ethics Committee.

Who cannot join

Have a history of mental illness before taking drugs;
Other substance use disorders (excluding nicotine);
Brain organic diseases, history of craniocerebral injury, history of coma;
Individuals with mental disorders who meet the DSM-5 diagnostic criteria within two generations;
History of endocrine diseases; Those with abnormal function in blood, heart, liver, and kidney after examination;
Intelligence impairment IQ.

Trial locations and contacts

1 site in 1 country.

China1 site

Sir Run Run Shaw Hospital
Hangzhou, Zhejiang, 310000

Other trials in China

About this study

Official title: The Effectiveness of Mindfulness-based Relapse Prevention: A Randomized Controlled Trial Study

This study developed a Mindfulness-based Relapse Prevention targeting craving. Based on the Randomized Controlled Trial design, 600 adult USD females and 600 adult USD males with methamphetamine, heroin, or ketamine in Intervention group(MBI) , the matched 250 subjects in Control group and 250 healthy matched controls (HC) participated in this study, 1200 adult USD subjects of Intervention group received the 8-week Group mindfulness intervention performed by psychiatrists. SUD patients were assessed three times, before, during(1-2 weeks after the MBI began), and after the intervention by a variety of clinical variables, cognitive task(reginal segmental task),fMRI and blood test to verify the effectiveness of the intervention method, attempting to expand the model of addiction and mindfulness.

Read the detailed description

The Group Mindfulness-based intervention adhered to structured formal procedures, conducted by psychiatrists, and was scheduled once a week, where each session spans for two hours, interspersed with a 10-minute break. Starting from the second intervention, the previous intervention's contents and home practice were reviewed at the beginning of each subsequent intervention.

Based on the Randomized Controlled Trial design, the evaluation time nodes for clinical variables, cognitive task(reginal segmental task),fMRI and blood test were baseline (before intervention), 1-2 weeks after intervention began, and after intervention. All clinical variable scales were presented in paper form, the questions were clearly explained by researchers.

Conditions: Substance Use Disorder
Being tested: Mindfulness-based Relapse Prevention
Keywords: addiction, Mindfulness-based Relapse Prevention, anxiety, depression, subliminal perception
Medical subject headings: Substance-Related Disorders, Behavior, Addictive, Anxiety Disorders, Depression

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Mindfulness-based Relapse PreventionBehavioural
250 adult USD females of Intervention group received the 8-week Group mindfulness intervention performed by psychiatrists.

Study groups in NCT06739304
Study group	Role	What they receive
Mindfulness-Based Relapse Prevention	Experimental	250 adult USD females of Intervention group received the 8-week Group mindfulness intervention performed by psychiatrists，and were assessed three times, before, during(1-2 weeks after the MBI began), and after the intervention by a variety of clinical variables, cognitive task(reginal segmental task),fMRI and blood test to verify the effectiveness of the intervention method, attempting to expand the model of addiction and mindfulness. Receives: Behavioral: Mindfulness-based Relapse Prevention
Control group	No intervention	the matched 250 females in Control group were assessed by the by a variety of clinical variables, cognitive task(reginal segmental task),FMRI and blood test.

What is being measured

The primary outcome is the main question the study is designed to answer.

Patient Health Questionnaire-Depression Scale (PHQ-9)
A quick depression assessment. The minimum score is 0 and maximum is 27. Higher scores indicate higher levels of depression. Minimal depression: scores 1-4. Mild depression: scores 5-9. Moderate depression: scores 10-14. Moderately severe depression: 15-19. Severe depression: 20-27.
Measured: before, during(1-2 weeks after the mindfulness-based intervention began), and immediately after the intervention
Beck Anxiety Inventory (BAI-21)
Anxiety Assessment with 21 items. Minimum score is 0, and maximum is 63. The higher scores indicate higher levels of anxiety.
Measured: before, during(1-2 weeks after the mindfulness-based intervention began), and immediately after the intervention
region segmental task
correct rate of reginal segmental task
Measured: before and immediately after the mindfulness-based intervention
fMRI
Brain structure and brain function
Measured: before, during(1-2 weeks after the mindfulness-based intervention began), and immediately after the intervention

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

10 Jun 202310 Nov 2023

First posted18 Dec 2024
Study start10 Jun 2023
Primary completion5 Aug 2023
Study completion10 Nov 2023

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (30)Papers the sponsor has linked to this study.
Other trials for Substance Use DisorderStudies of the same condition, open and under way.
More trials run by Sir Run Run Shaw HospitalThe sponsor's other registered studies.
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: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 1,200 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06739304
Sponsor's protocol ID: U22A20302
Status last verified: Dec 2024
First submitted: 30 Nov 2023
Last updated: 1 Apr 2025
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No: Due to ethical and privacy consideration, IPD might not be shared

Publications

Carroll KM, Kiluk BD. Cognitive behavioral interventions for alcohol and drug use disorders: Through the stage model and back again. Psychol Addict Behav. 2017 Dec;31(8):847-861. doi: 10.1037/adb0000311. Epub 2017 Aug 31.
PubMed 28857574
Da Silva Roggi P M, Da Gama M F N, Neves F S, et al. Update on treatment of craving in patients with addiction using cognitive behavioral therapy
Mohan UR, Watrous AJ, Miller JF, Lega BC, Sperling MR, Worrell GA, Gross RE, Zaghloul KA, Jobst BC, Davis KA, Sheth SA, Stein JM, Das SR, Gorniak R, Wanda PA, Rizzuto DS, Kahana MJ, Jacobs J. The effects of direct brain stimulation in humans depend on frequency, amplitude, and white-matter proximity. Brain Stimul. 2020 Sep-Oct;13(5):1183-1195. doi: 10.1016/j.brs.2020.05.009. Epub 2020 May 21.
PubMed 32446925
Solinas M, Belujon P, Fernagut PO, Jaber M, Thiriet N. Dopamine and addiction: what have we learned from 40 years of research. J Neural Transm (Vienna). 2019 Apr;126(4):481-516. doi: 10.1007/s00702-018-1957-2. Epub 2018 Dec 19.
PubMed 30569209
Hare BD, Duman RS. Prefrontal cortex circuits in depression and anxiety: contribution of discrete neuronal populations and target regions. Mol Psychiatry. 2020 Nov;25(11):2742-2758. doi: 10.1038/s41380-020-0685-9. Epub 2020 Feb 21.
PubMed 32086434
Wydra K, Suder A, Frankowska M, Borroto Escuela DO, Fuxe K, Filip M. Effects of intra-accumbal or intra-prefrontal cortex microinjections of adenosine 2A receptor ligands on responses to cocaine reward and seeking in rats. Psychopharmacology (Berl). 2018 Dec;235(12):3509-3523. doi: 10.1007/s00213-018-5072-8. Epub 2018 Nov 13.
PubMed 30426181
Feil J, Zangen A. Brain stimulation in the study and treatment of addiction. Neurosci Biobehav Rev. 2010 Mar;34(4):559-74. doi: 10.1016/j.neubiorev.2009.11.006. Epub 2009 Nov 13.
PubMed 19914283
Hoppes K. The application of mindfulness-based cognitive interventions in the treatment of co-occurring addictive and mood disorders. CNS Spectr. 2006 Nov;11(11):829-51. doi: 10.1017/s1092852900014991.
PubMed 17075556
Chen P, Jindani F, Perry J, et al. Mindfulness and problem gambling treatment
Grant S, Colaiaco B, Motala A, Shanman R, Booth M, Sorbero M, Hempel S. Mindfulness-based Relapse Prevention for Substance Use Disorders: A Systematic Review and Meta-analysis. J Addict Med. 2017 Sep/Oct;11(5):386-396. doi: 10.1097/ADM.0000000000000338.
PubMed 28727663
Witkiewitz K, Lustyk MKB, Bowen S. Retraining the addicted brain: a review of hypothesized neurobiological mechanisms of mindfulness-based relapse prevention. Psychol Addict Behav. 2013 Jun;27(2):351-365. doi: 10.1037/a0029258. Epub 2012 Jul 9.
PubMed 22775773
Chambers R, Lo B C Y, Allen N B. The impact of intensive mindfulness training on attentional control, cognitive style, and affect
Bowen S, Chawla N, Collins SE, Witkiewitz K, Hsu S, Grow J, Clifasefi S, Garner M, Douglass A, Larimer ME, Marlatt A. Mindfulness-based relapse prevention for substance use disorders: a pilot efficacy trial. Subst Abus. 2009 Oct-Dec;30(4):295-305. doi: 10.1080/08897070903250084.
PubMed 19904665
Winhall J. Treating trauma and addiction with the felt sense polyvagal model: A bottom-up approach
Froeliger B, McConnell PA, Stankeviciute N, McClure EA, Kalivas PW, Gray KM. The effects of N-Acetylcysteine on frontostriatal resting-state functional connectivity, withdrawal symptoms and smoking abstinence: A double-blind, placebo-controlled fMRI pilot study. Drug Alcohol Depend. 2015 Nov 1;156:234-242. doi: 10.1016/j.drugalcdep.2015.09.021. Epub 2015 Sep 26.
PubMed 26454838

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Healthy Volunteers

All Substance Use Disorder trials

Study at a glance

From the registry record, last updated by the sponsor on 1 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: The Effectiveness of Mindfulness-based Relapse Prevention: A Randomized Controlled Trial Study
ClinicalTrials.gov ID: NCT06739304
Acronym / sponsor ID: U22A20302
Conditions: Substance Use Disorder
Keywords: addiction, Mindfulness-based Relapse Prevention, anxiety, depression, subliminal perception
Study type: Interventional
Recruitment status: Completed
Enrolment: 1,200 participants (actual)
Lead sponsor: Sir Run Run Shaw HospitalUniversity, hospital or other
Study start: 10 Jun 2023 (actual)
Primary completion: 5 Aug 2023 (actual)
Study completion: 10 Nov 2023 (actual)
First posted: 18 Dec 2024 (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.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Mindfulness-Based Relapse Prevention	Experimental	Behavioral: Mindfulness-based Relapse Prevention250 adult USD females of Intervention group received the 8-week Group mindfulness intervention performed by psychiatrists，and were assessed three times, before, during(1-2 weeks after the MBI began), and after the intervention by a variety of clinical variables, cognitive task(reginal segmental task),fMRI and blood test to verify the effectiveness of the intervention method, attempting to expand the model of addiction and mindfulness.
Control group	No intervention	–the matched 250 females in Control group were assessed by the by a variety of clinical variables, cognitive task(reginal segmental task),FMRI and blood test.

Who may qualify

Ages: 25 to 57 years
Sex: Female only
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (5 listed)

Meets the diagnostic criteria for DSM-5 of substance use disorders;
The duration of using the addictive substance shall not be less than 1 year;
Prohibit addictive substances for at least 48 hours before conducting magnetic resonance imaging scans;
Han nationality, junior high school or above education level, aged 18-57 years old;
Informed and agreed to participate in this study, with the consent of the Ethics Committee.

Key exclusion criteria (6 listed)

Have a history of mental illness before taking drugs;
Other substance use disorders (excluding nicotine);
Brain organic diseases, history of craniocerebral injury, history of coma;
Individuals with mental disorders who meet the DSM-5 diagnostic criteria within two generations;
History of endocrine diseases; Those with abnormal function in blood, heart, liver, and kidney after examination;

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
Mindfulness-based Relapse Prevention250 adult USD females of Intervention group received the 8-week Group mindfulness intervention performed by psychiatrists.	Behavioural	Mindfulness-Based Relapse Prevention

Primary outcome

Patient Health Questionnaire-Depression Scale (PHQ-9)
Time frame: before, during(1-2 weeks after the mindfulness-based intervention began), and immediately after the intervention
A quick depression assessment. The minimum score is 0 and maximum is 27. Higher scores indicate higher levels of depression. Minimal depression: scores 1-4. Mild depression: scores 5-9. Moderate depression: scores 10-14. Moderately severe depression: 15-19. Severe depression: 20-27.
Beck Anxiety Inventory (BAI-21)
Time frame: before, during(1-2 weeks after the mindfulness-based intervention began), and immediately after the intervention
Anxiety Assessment with 21 items. Minimum score is 0, and maximum is 63. The higher scores indicate higher levels of anxiety.
region segmental task
Time frame: before and immediately after the mindfulness-based intervention
correct rate of reginal segmental task
fMRI
Time frame: before, during(1-2 weeks after the mindfulness-based intervention began), and immediately after the intervention
Brain structure and brain function

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 1 Apr 2025.
Results publication: PubMed 28857574Carroll KM, Kiluk BD. Cognitive behavioral interventions for alcohol and drug use disorders: Through the stage model and back again. Psychol Addict Behav. 2017 Dec;31(8):847-861. doi: 10.1037/adb0000311. Epub 2017 Aug 31.
Results publicationDa Silva Roggi P M, Da Gama M F N, Neves F S, et al. Update on treatment of craving in patients with addiction using cognitive behavioral therapy
Results publication: PubMed 32446925Mohan UR, Watrous AJ, Miller JF, Lega BC, Sperling MR, Worrell GA, Gross RE, Zaghloul KA, Jobst BC, Davis KA, Sheth SA, Stein JM, Das SR, Gorniak R, Wanda PA, Rizzuto DS, Kahana MJ, Jacobs J. The effects of direct brain stimulation in humans depend on frequency, amplitude, and white-matter proximity. Brain Stimul. 2020 Sep-Oct;13(5):1183-1195. doi: 10.1016/j.brs.2020.05.009. Epub 2020 May 21.
Results publication: PubMed 30569209Solinas M, Belujon P, Fernagut PO, Jaber M, Thiriet N. Dopamine and addiction: what have we learned from 40 years of research. J Neural Transm (Vienna). 2019 Apr;126(4):481-516. doi: 10.1007/s00702-018-1957-2. Epub 2018 Dec 19.
Results publication: PubMed 32086434Hare BD, Duman RS. Prefrontal cortex circuits in depression and anxiety: contribution of discrete neuronal populations and target regions. Mol Psychiatry. 2020 Nov;25(11):2742-2758. doi: 10.1038/s41380-020-0685-9. Epub 2020 Feb 21.
Results publication: PubMed 30426181Wydra K, Suder A, Frankowska M, Borroto Escuela DO, Fuxe K, Filip M. Effects of intra-accumbal or intra-prefrontal cortex microinjections of adenosine 2A receptor ligands on responses to cocaine reward and seeking in rats. Psychopharmacology (Berl). 2018 Dec;235(12):3509-3523. doi: 10.1007/s00213-018-5072-8. Epub 2018 Nov 13.
Results publication: PubMed 19914283Feil J, Zangen A. Brain stimulation in the study and treatment of addiction. Neurosci Biobehav Rev. 2010 Mar;34(4):559-74. doi: 10.1016/j.neubiorev.2009.11.006. Epub 2009 Nov 13.
Results publication: PubMed 17075556Hoppes K. The application of mindfulness-based cognitive interventions in the treatment of co-occurring addictive and mood disorders. CNS Spectr. 2006 Nov;11(11):829-51. doi: 10.1017/s1092852900014991.
Results publicationChen P, Jindani F, Perry J, et al. Mindfulness and problem gambling treatment
Results publication: PubMed 28727663Grant S, Colaiaco B, Motala A, Shanman R, Booth M, Sorbero M, Hempel S. Mindfulness-based Relapse Prevention for Substance Use Disorders: A Systematic Review and Meta-analysis. J Addict Med. 2017 Sep/Oct;11(5):386-396. doi: 10.1097/ADM.0000000000000338.
Results publication: PubMed 22775773Witkiewitz K, Lustyk MKB, Bowen S. Retraining the addicted brain: a review of hypothesized neurobiological mechanisms of mindfulness-based relapse prevention. Psychol Addict Behav. 2013 Jun;27(2):351-365. doi: 10.1037/a0029258. Epub 2012 Jul 9.
Results publicationChambers R, Lo B C Y, Allen N B. The impact of intensive mindfulness training on attentional control, cognitive style, and affect
Individual participant dataSharing planned: No. Due to ethical and privacy consideration, IPD might not be shared

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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.

Yanhui Liao, MD study director

Sir Run Run Shaw Hospital

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Mindfulness-based Relapse Prevention in people with Substance Use Disorder, run by Sir Run Run Shaw Hospital at 1 site in China.

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 6 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 1 Apr 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 China. 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?

Patient Health Questionnaire-Depression Scale (PHQ-9) (time frame: before, during(1-2 weeks after the mindfulness-based intervention began), and immediately after the intervention). The study lists 4 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 NCT06739304, which also lists 30 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 1 Apr 2025.