A Pilot Study of Non-invasive Brain Stimulation to Boost the Efficacy of Psychotherapy in a Community Sample of People Who Drink Alcohol

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age21-60
SponsorThe Mind Research Network

About this trial

The goal of this small (n=75) proof-of-concept randomized clinical trial is to test the effects of transcranial alternating current stimulation (tACS) during motivational interviewing (MI) sessions with participants who drink at above the low-risk level. Participants will be randomized to receive either MI with active stimulation, MI with sham stimulation, or a delayed treatment group that receives MI with no stimulation. Measures will include brain imaging, alcohol use, cannabis use, risk-taking behavior, emotions, and others. Participants who are randomized to the delayed-treatment group will not receive brain imaging.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Self-identify as having problem drinking

Right-handed

Age 21-60 years

AUDIT score indicating risky drinking

Disqualifiers

Left-handed or ambidextrous

Currently engaged in treatment for alcohol use disorder

Receiving treatment for alcohol use disorder within the prior 12 months

History of brain injury or neurological diagnosis

Trial design

Design model

Parallel

Treatments tested in this trial

  • High-density transcranial alternating current stimulation

    Device

    High-density electrode configuration with transcranial alternating current stimulation in the beta (15-40Hz) frequency range

  • Sham stimulation

    Device

    High-density electrode configuration with sham stimulation

  • Motivational interviewing

    Behavioral

    Motivational interviewing session focused on alcohol use, approximately 30 minutes in length

Treatment groups

75 Participants
are divided into 3 treatment groups
Group A: MI with tACSExperimental treatment 2 interventions
Group B: MI with shamSham comparator 2 interventions
Group C: MI-onlyActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Heavy drinking days

Number of heavy drinking days in the prior 30 days

Time frame
One month

Secondary outcomes

1

Drinks per drinking day

Number of drinks per drink day in the prior 30 days

Time frame
One month
2

Percent days abstinent

Percent days abstinent in the prior 30 days

Time frame
One month

Other outcomes

Sponsors and contacts

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The Mind Research Network

Lead sponsor

National Institute of General Medical Sciences (NIGMS)

Collaborator