Neuromodulation and Cognitive Training in Opioid Use Disorder

Part of paid clinical trials in Minneapolis, Minnesota.

Sponsor
University of Minnesota
Study ID
NCT03773523
Status
Recruiting
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Conditions

  • Opioid Abuse
  • Opioid Dependence
  • Opioid-use Disorder

Eligibility Criteria

Sex
ALL
Age
18 Years - 60 Years
Healthy Volunteers
Not accepted

Interventions

  • Transcranial Direct Current Stimulation (tDCS) — DEVICE
    tDCS will be performed with Neuroelectrics Starstim Enobio 20, a non-invasive investigational device that has been labeled as a non-significant risk device by the FDA. This study is regulated by the FDA as an Abbreviated IDE. It has built-in safety mechanisms which allow for immediate cessation of stimulation if the subject becomes uncomfortable. The current will be administered via two electrode sponges for 25 mins with 1-2 milliamperes. These administration protocols are in line with protocols that have outlined safe administration (Nitsche 2007; 2008). No side-effects have been reported with the exception of slight itching under the electrode and occasional occurrence of headache, fatigue, or nausea (Poreisz 2007). Electrodes placement: dorsolateral prefrontal cortex (DLPFC); cathode on left DLPFC, anode on right DLPFC.

Study Details

The relapsing nature of opioid use disorder is a major obstacle to successful treatment. About 90% of those entering treatment will relapse within one year. To improve treatment outcome, new interventions targeting the underlying brain biomarkers of relapse vulnerability hold significant promise in reducing this critical public health problem. Transcranial direct current stimulation (tDCS) is a non-invasive brain stimulation technique that can modulate brain connectivity.

Key Dates

Start date
Aug 1, 2019
Status verified
May 2026
Primary completion
May 15, 2027
Completion
May 15, 2027

Study Design

Enrollment
30 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DEVICE_FEASIBILITY

Arms

  • Experimental: Experimental: active tDCS
    Subjects that are randomly assigned to this arm will undergo 5 sessions of tDCS.
  • Sham Comparator: Sham Comparator: sham tDCS
    Subjects randomly assigned to sham-tDCS will receive very low current stimulation at the beginning and end of the session, mimicking the feeling of current stimulation in the scalp, but not reaching levels that will stimulate brain function. There will be a total of 5 sham tDCS sessions.

Primary Outcome Measure

Change in brain functional connectivity as measured by functional magnetic resonance imaging [ Time Frame: Change between baseline and 1-week follow-up ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of MinnesotaMinneapolisMinnesota55414
Jazmin Y Camchong, PhD
[email protected]
612-624-0134
Jazmin Y Camchong, PhD (PRINCIPAL_INVESTIGATOR)
Kelvin O Lim, MD (SUB_INVESTIGATOR)

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By research site
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