Health TrialsbyHealthPanel

Brain Mechanisms of Reducing Polysubstance Use

ConditionMultiple Drug Use
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorArizona State University

About this trial

The proposed study will test whether neurofeedback (NF) could optimize integrative body-mind training (IBMT) practice.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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

Disqualifiers

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 design

Design model

Parallel

Treatments tested in this trial

  • IBMT

    Behavioral

    IBMT is an effortless mindfulness technique

  • NF

    Behavioral

    NF is a mental training technique.

Treatment groups

35 Participants
are divided into 4 treatment groups
Group A: IBMTExperimental treatment 1 intervention
Group B: NFExperimental treatment 1 intervention
Group C: IBMT + NFExperimental treatment 2 interventions
Group D: Sham NFSham comparator 1 intervention

Trial outcomes

Primary outcomes

1

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

Time frame
The outcome measures are assessed in-person at baseline, 2-4 weeks and 3 months
2

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

Time frame
The outcome measures are assessed in-person at baseline, 2-4 weeks and 3 months
3

Intervention effects on brain grey matter using fMRI

Brain volume changes such as anterior and posterior cingulate cortex measured by fMRI structural imaging

Time frame
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

Time frame
The outcome measures are assessed in-person at baseline, 2-4 weeks and 3 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Arizona State University

Lead sponsor

Source ClinicalTrials.gov
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