Multiple Drug UseNCT06324786
Brain Mechanisms of Reducing Polysubstance Use
A study testing IBMT and NF in people with Multiple Drug Use, run by Arizona State University at 1 site in United States.
Trial summary
The proposed study will test whether neurofeedback (NF) could optimize integrative body-mind training (IBMT) practice. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Multiple Drug Use
- What is being tested?
- IBMT and NF
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 35 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Sep 2023to 31 Aug 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- At least 18 years old
- Free of any psychiatric diagnoses or medication (besides a substance use disorder (SUD) to alcohol, tobacco, or cannabis)
- In the past month, at least 4 episodes of heavy episodic drinking; at least 3 occasions of cannabis use; and daily cigarette use for at least the past month
- Normal or corrected-to-normal vision
- Written informed consent
- No previous meditation or NF experiences
Who cannot join
- Any psychiatric diagnoses other than an SUD
- Medical disorder(s) that may affect the central nervous system; medications that affect the central and autonomic nervous system; or a positive pregnancy test result (females)
- Excluding cannabis, evidence of recent (past month) illicit drug use
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
YiYuan Tang
Phoenix, Arizona, 85004
YiYuan Tang, 4807903577, yiyuan@asu.edu
About this study
Official title: Brain Mechanisms of Reducing Polysubstance Use Following a Novel Body-mind Intervention 2
The proposed study will test whether neurofeedback (NF) could optimize integrative body-mind training (IBMT) practice.
Read the detailed description
The proposed study will test whether real-time NF could optimize IBMT practice and improve effects in reducing polysubstance use through targeting self-control networks in the brain.
- Conditions
- Multiple Drug Use
- Being tested
- IBMT, NF
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IBMTBehavioural
IBMT is an effortless mindfulness technique
NFBehavioural
NF is a mental training technique.
| Study group | Role | What they receive |
|---|---|---|
| IBMT | Experimental | An evidence-based preventive intervention - integrative body-mind training (IBMT) has shown positive effects in reducing stress and improving self-control and brain plasticity. It has bodifulness and mindfulness components. Receives: Behavioral: IBMT |
| NF | Experimental | An evidence-based intervention - NF can not only provide real-time feedback for practice but also target the self-control networks, suggesting the possibility of augmenting IBMT effects via NF. Receives: Behavioral: NF |
| IBMT + NF | Experimental | The combined IBMT and NF also show positive effects in reducing substance use. Receives: Behavioral: IBMT; Behavioral: NF |
| Sham NF | Sham comparator | Sham NF has the same settings as the active NF but does not have correct parameters of stimulation. Receives: Behavioral: NF |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intervention effects on brain function using Functional Magnetic Resonance Imaging (fMRI)
Brain connectivity changes such as anterior and posterior cingulate cortex measured by fMRI resting state imaging
Measured: The outcome measures are assessed in-person at baseline, 2-4 weeks and 3 months
Intervention effects on brain white matter using fMRI
Brain white matter changes such as anterior and posterior cingulate cortex measured by fMRI diffusion tensor imaging
Measured: The outcome measures are assessed in-person at baseline, 2-4 weeks and 3 months
Intervention effects on brain grey matter using fMRI
Brain volume changes such as anterior and posterior cingulate cortex measured by fMRI structural imaging
Measured: The outcome measures are assessed in-person at baseline, 2-4 weeks and 3 months
Secondary outcomes (1)
Intervention effects on addiction behavior using substance use questionnaires in PhenX Toolkit
Intervention leads to a significant reduction in craving and substance use measured by substance use questionnaires in PhenX Toolkit
Measured: The outcome measures are assessed in-person at baseline, 2-4 weeks and 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Mar 2024
- Study start1 Sep 2023
- Primary completion31 Aug 2027 (estimated)
- Study completion31 Aug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple Drug UseStudies 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- mindfulness or/and active/sham neurofeedback
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 35 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Arizona State University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06324786
- Sponsor's protocol ID
- 2024 IBMT NF
- Status last verified
- May 2026
- First submitted
- 6 Mar 2024
- Last updated
- 4 May 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Brain Mechanisms of Reducing Polysubstance Use Following a Novel Body-mind Intervention 2
- ClinicalTrials.gov ID
- NCT06324786
- Acronym / sponsor ID
- 2024 IBMT NF
- Conditions
- Multiple Drug Use
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 35 participants (estimated)
- Lead sponsor
- Arizona State UniversityUniversity, hospital or other
- Study start
- 1 Sep 2023 (actual)
- Primary completion
- 31 Aug 2027 (estimated)
- Study completion
- 31 Aug 2027 (estimated)
- First posted
- 22 Mar 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.
The proposed study will test whether neurofeedback (NF) could optimize integrative body-mind training (IBMT) practice.
Detailed description
The proposed study will test whether real-time NF could optimize IBMT practice and improve effects in reducing polysubstance use through targeting self-control networks in the brain.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
- Model description
- mindfulness or/and active/sham neurofeedback
| Arm | Type | Receives |
|---|---|---|
| IBMT | Experimental | Behavioral: IBMTAn evidence-based preventive intervention - integrative body-mind training (IBMT) has shown positive effects in reducing stress and improving self-control and brain plasticity. It has bodifulness and mindfulness components. |
| NF | Experimental | Behavioral: NFAn evidence-based intervention - NF can not only provide real-time feedback for practice but also target the self-control networks, suggesting the possibility of augmenting IBMT effects via NF. |
| IBMT + NF | Experimental | Behavioral: IBMT, Behavioral: NFThe combined IBMT and NF also show positive effects in reducing substance use. |
| Sham NF | Sham comparator | Behavioral: NFSham NF has the same settings as the active NF but does not have correct parameters of stimulation. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- At least 18 years old
- Free of any psychiatric diagnoses or medication (besides a substance use disorder (SUD) to alcohol, tobacco, or cannabis)
- In the past month, at least 4 episodes of heavy episodic drinking; at least 3 occasions of cannabis use; and daily cigarette use for at least the past month
- Normal or corrected-to-normal vision
- Written informed consent
Key exclusion criteria (3 listed)
- Any psychiatric diagnoses other than an SUD
- Medical disorder(s) that may affect the central nervous system; medications that affect the central and autonomic nervous system; or a positive pregnancy test result (females)
- Excluding cannabis, evidence of recent (past month) illicit drug use
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 |
|---|---|---|
| IBMTIBMT is an effortless mindfulness technique | Behavioural | IBMT, IBMT + NF |
| NFNF is a mental training technique. | Behavioural | IBMT + NF, NF, Sham NF |
Primary outcome
Intervention effects on brain function using Functional Magnetic Resonance Imaging (fMRI)
Time frame: The outcome measures are assessed in-person at baseline, 2-4 weeks and 3 months
Brain connectivity changes such as anterior and posterior cingulate cortex measured by fMRI resting state imaging
Intervention effects on brain white matter using fMRI
Time frame: The outcome measures are assessed in-person at baseline, 2-4 weeks and 3 months
Brain white matter changes such as anterior and posterior cingulate cortex measured by fMRI diffusion tensor imaging
Intervention effects on brain grey matter using fMRI
Time frame: The outcome measures are assessed in-person at baseline, 2-4 weeks and 3 months
Brain volume changes such as anterior and posterior cingulate cortex measured by fMRI structural imaging
1 secondary outcome
Intervention effects on addiction behavior using substance use questionnaires in PhenX Toolkit
Time frame: The outcome measures are assessed in-person at baseline, 2-4 weeks and 3 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 May 2026.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing IBMT and NF in people with Multiple Drug Use, run by Arizona State University at 1 site in United States.
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 6 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: looking for participants now, as of the sponsor's last update on 4 May 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 United States. 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. Some participants in this study may receive a placebo. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact YiYuan Tang (4807903577, yiyuan@asu.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Intervention effects on brain function using Functional Magnetic Resonance Imaging (fMRI) (time frame: The outcome measures are assessed in-person at baseline, 2-4 weeks and 3 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 4 May 2026.