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 volunteersQualifiers
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
Factorial
Treatments tested in this trial
Transcranial Direct Current Stimulator (tDCS)
DeviceParticipants 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
BehavioralCognitive reappraisal of drug cues during stimulation sessions
Treatment groups
Trial outcomes
Primary outcomes
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.
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.
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Icahn School of Medicine at Mount Sinai
Lead sponsor
National Institute on Drug Abuse (NIDA)
Collaborator
Soterix Medical
Collaborator