Transcranial Direct Current Stimulation (tDCS) for Treatment of Substance Use Disorder

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-60
SponsorIcahn School of Medicine at Mount Sinai

About this trial

The researchers will test whether cognitively enhanced transcranial direct current stimulation (tDCS) of the dorsolateral prefrontal cortex can reduce craving in inpatients with cocaine use disorder or opioid use disorder. Neuroimaging before and after stimulation will establish the neural correlates of recovery and allow predictions of outcomes, which will be assessed throughout the study and one month after its completion. Results could pave the way towards development of a new self-administered intervention to reduce craving when it is needed the most, enhancing recovery real-time and in the natural environment in people with cocaine addiction as generalizable to other drugs of abuse and other disorders of self-control.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Ability to understand and give informed consent

Men and women 18-60 years of age.

For women of childbearing potential, current use of a medically acceptable form of birth control

DSM-5 diagnosis of stimulant use disorder with crack/cocaine as the drug of choice or opioid use disorder

Disqualifiers

Lifetime diagnosis of schizophrenia, schizoaffective disorder, schizophreniform disorder, bipolar I disorder, or delusional disorder as confirmed by the MINI or autism spectrum disorder as confirmed by medical history at the screening visit

Current clinically significant or unstable medical conditions, including metabolic, endocrinological, oncological or autoimmune diseases, infectious diseases common in people with substance use disorders including Hepatitis B and C or HIV/AIDS; use of medications deemed exclusionary by the study team; or any laboratory value outside the reference range that the senior investigator team considers to be of clinical relevance

Head trauma with loss of consciousness (>30 min)

History of neurological or developmental disease of central origin including stroke, brain tumor or seizures, encompassing those symptoms associated with periods of drug withdrawal or abstinence

Trial design

Design model

Factorial

Treatments tested in this trial

  • Transcranial Direct Current Stimulator (tDCS)

    Device

    Participants will have two electrodes applied (one anode, one cathode) administering active (real) or sham (placebo, not real) tDCS stimulation of the dorsolateral prefrontal cortex. Stimulation will last 20 minutes per day, three days per week, for 5 weeks

  • Cognitive Reappraisal Training

    Behavioral

    Cognitive reappraisal of drug cues during stimulation sessions

Treatment groups

240 Participants
are divided into 4 treatment groups
Group A: Active tDCS with Cognitive Reappraisal (CR)Experimental treatment 2 interventions
Group B: Active tDCSExperimental treatment 1 intervention
Group C: Sham tDCSSham comparator 1 intervention
Group D: Sham tDCS with Cognitive Reappraisal (CR)Experimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

fMRI blood-oxygenation level dependent (BOLD) signal

Neuroimaging - Measure of fMRI blood-oxygenation level dependent (BOLD) signal in the dorsolateral prefrontal cortex before and immediately after 5 weeks of tDCS.

Time frame
At baseline and immediately after 5 weeks of tDCS.
2

Change in Self-Reported Craving Score

Changes in measures of craving cocaine craving on a 0-9 point scale in response to interventions, with high scores indicating higher craving.

Time frame
At baseline, immediately after 5 weeks of tDCS, and 1 month after interventions.

Secondary outcomes

Other outcomes

Sponsors and contacts

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Icahn School of Medicine at Mount Sinai

Lead sponsor

National Institute on Drug Abuse (NIDA)

Collaborator

Soterix Medical

Collaborator