Neuromodulation and Cognitive Training in Opioid Use Disorder

NCT03773523 | Recruiting DMC FDA Device

• 1 other identifier: PSYCH-2018-27116
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Opioid-use Disorder; Opioid Dependence; Opioid Abuse

Keywords

tDCS; Transcranial Direct Current Stimulation; MRI; Opioid dependence; Opioids; Buprenorphine; Suboxone; Lodging Plus; Fairview Lodging Plus

Outcome Measures

Primary Outcomes (1)

• Change in brain functional connectivity as measured by functional magnetic resonance imaging

  Investigators will measure magnitude of functional connectivity in between nucleus accumbens (NAcc) and prefrontal cortex (PFC) both at baseline and at follow-up and compare the magnitude of change between the active-tDCS and sham-tDCS groups.

  Change between baseline and 1-week follow-up

Secondary Outcomes (2)

• Correlation between functional connectivity change and craving scores

  Data collection will be during 2 and 3 weeks of abstinence

• Correlation between functional connectivity change and clinical outcome

  Between 2 weeks of abstinence and 2 months later

Study Arms (2)

Experimental: active tDCS

EXPERIMENTAL

Subjects that are randomly assigned to this arm will undergo 5 sessions of tDCS.

Device: Transcranial Direct Current Stimulation (tDCS)

Sham Comparator: sham tDCS

SHAM COMPARATOR

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.

Device: Transcranial Direct Current Stimulation (tDCS)

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.

Also known as: Starstim

Experimental: active tDCS; Sham Comparator: sham tDCS

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• abstinent individuals (18-60 years old; 1-2 weeks of abstinence) who meet DSM-V criteria for opioid use disorder (OUD) will be recruited from the Lodging Plus Program, part of University of Minnesota Medical Center
• This 28-day program provides a supervised environment to treat individuals with OUD in which patients receive random drug screenings. Lodging Plus has 50 beds and admits an average of 20 patients per week and about 50% of patients admitted have a diagnosis of opioid use disorder.
• Ability to provide written consent and comply with study procedures, meet the Diagnostic and Statistical Manual of Mental Disorders (DSM-V) diagnostic criteria for OUD. Subjects may have current comorbid drug use, but their primary substance use disorder diagnosis needs to be based on opioid use. Subjects must have the intention to remain in the Lodging Plus program (4 weeks) until the end of the intervention portion of the study. Vulnerable populations will not be included.

You may not qualify if:

• Any medical condition or treatment with neurological sequelae (i.e. stroke, tumor, loss of consciousness\>30 min, HIV)
• A head injury resulting in a skull fracture or a loss of consciousness exceeding 30 minutes (i.e., moderate or severe TBI)
• Any contraindications for tDCS or MRI scanning (tDCS contraindication: history of seizures; MRI contraindications; metal implants, pacemakers or any other implanted electrical device, injury with metal, braces, dental implants, non-removable body piercings, pregnancy, breathing or moving disorder)
• DSM-V criteria for psychiatric disorder, may have a lifetime diagnosis of depression
• Presence of a condition that would render study measures difficult or impossible to administer or interpret
• Age outside the range of 18 to 60
• Primary current substance use disorder diagnosis on a substance other than opioid except for caffeine or nicotine
• Clinical evidence for Wernicke-Korsakoff syndrome
• Nicotine use will be recorded.

Sponsors & Collaborators

• University of Minnesota: lead

Study Sites (1)

University of Minnesota

Minneapolis, Minnesota, 55414, United States

RECRUITING

Related Publications (3)

• Camchong J, Macdonald AW 3rd, Mueller BA, Nelson B, Specker S, Slaymaker V, Lim KO. Changes in resting functional connectivity during abstinence in stimulant use disorder: a preliminary comparison of relapsers and abstainers. Drug Alcohol Depend. 2014 Jun 1;139:145-51. doi: 10.1016/j.drugalcdep.2014.03.024. Epub 2014 Mar 29.

  PMID: 24745476 BACKGROUND

• Camchong J, Stenger A, Fein G. Resting-state synchrony during early alcohol abstinence can predict subsequent relapse. Cereb Cortex. 2013 Sep;23(9):2086-99. doi: 10.1093/cercor/bhs190. Epub 2012 Jul 20.

  PMID: 22819968 BACKGROUND

• Camchong J, Stenger VA, Fein G. Resting-state synchrony in short-term versus long-term abstinent alcoholics. Alcohol Clin Exp Res. 2013 May;37(5):794-803. doi: 10.1111/acer.12037. Epub 2013 Feb 19.

  PMID: 23421812 BACKGROUND

MeSH Terms

Conditions

Opioid-Related Disorders

Interventions

Transcranial Direct Current Stimulation

Condition Hierarchy (Ancestors)

Narcotic-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Convulsive Therapy; Psychiatric Somatic Therapies; Behavioral Disciplines and Activities; Electroshock; Psychological Techniques

Study Officials

• Jazmin Y Camchong, PhD

  University of Minnesota

  PRINCIPAL INVESTIGATOR

• Kelvin O Lim, MD

  University of Minnesota

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jazmin Y Camchong, PhD

CONTACT

(612) 624-0134; camch002@umn.edu

Lamisa N Chowdhury, BS

CONTACT

(612) 626-6808; chow0082@umn.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Participants will not be informed on their assigned protocol. During consent, they will be informed that there is a 50% chance of being assigned either to the group receiving active tDCS or the group receiving sham tDCS. The Principal Investigator and research staff will also be blind to the condition the participant is assigned to.
• Purpose: DEVICE FEASIBILITY
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This study is randomized, double-blind, and sham-controlled. Participants will be randomly assigned to either active or sham tDCS. We are testing device feasibility, safety, and circuit-based targeted engagement.

Study Record Dates

• First Submitted: December 10, 2018
• First Posted: December 12, 2018
• Study Start: August 1, 2019
• Primary Completion (Estimated): May 15, 2026
• Study Completion (Estimated): May 15, 2026
• Last Updated: June 12, 2025

Record last verified: 2025-06

Locations

US (1)