tDCS and Impulsivity

Status unconfirmed · Not applicable · Has a placebo group

Conditions studied: Substance Use Disorders, Substance Abuse, Substance Use

In brief

Substance use disorder (SUD) affects more than 23 million Americans and claims more than 70,000 lives annually. With 40-60% relapse rate, SUD patients are high hospital utilizers, 65% of the incarcerated population, and are at high-risk for overdose and deaths. There is a pressing need for research in this area to advance beyond traditional pharmacological and behavioral therapies toward a greater focus on the mechanisms of risk for relapse and to improve personalization for SUD treatment. Neuromodulation has shown promise to stimulate neuronal growth without any of the side effects of medications or electroconvulsive therapy. Using transcranial direct current stimulation (tDCS) to modulate cortical activity has shown to be a viable therapy in medicine-resistant depression, to reduce opioid cravings, and impulse control. The proposed research plans to recruit 30 subjects with a history of substance use disorder (SUD). This may include a history of addiction to opioids, cocaine, and barbiturates. Addiction to alcohol and cannabinoids (marijuana) will be excluded from this study. Following recruitment and consent, the subject will be administered an EEG, Acceptance Commitment Therapy exercise followed by EEG, and a BIS-11 Survey measuring levels of impulsivity. During the next week, the patient will undergo 5 visits consisting of a pre-EEG, tDCS, and post-EEG. Half of the subjects (n=15) will receive treatment, while the other half will be in a sham group. After the completion of the 5 tDCS visits, the patient will again be administered an EEG, ACT exercise followed by EEG, and a final BIS-11 survey measuring for end impulsivity levels.

Key facts

Study ID: NCT05845164
Run by: University of Arizona
People needed: 30
Starts: 2023-06-01
Expected to finish: 2023-10-11
Last updated by the study team: 2023-05-06

Who can join

Age: 18 and older, up to 79. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

Age: 18-79 years old
Gender: Any
Ethnicity: Any
Diagnosis of substance use disorder and a recent history of substance use (<24 months last use), but not currently reporting use.

You may not qualify if…

Diagnosis (as defined by DSM-IV) of: any psychotic disorder (lifetime); eating disorder (current or within the past year); obsessive compulsive disorder (lifetime)); mental retardation.
History of drug or alcohol abuse or dependence (as per DSM-IV criteria) within the last 3 months (except nicotine and caffeine).
Subject is on regular benzodiazepine medication which it is not clinically appropriate to discontinue.
Subject requires a rapid clinical response due to inanition, psychosis or high suicide risk.
Neurological disorder or insult, e.g., recent stroke (CVA), which places subject at risk of seizure or neuronal damage with tDCS.
Subject has metal in the cranium, skull defects, or skin lesions on scalp (cuts, abrasions, rash) at proposed electrode sites.
Female subject who is pregnant.
Participants who are not fluent in English will not be included in the trial for safety reasons: a) It is usually not possible to have an interpreter reliably available every weekday for up to 4 weeks and it is not safe to give tDCS to a subject who cannot tell us immediately of any side effects; Note that translation of the proposed ACT activity into English has not been validated and that we cannot be confident that they would be accurately translated and validated.
Minors
Older than 79 years old
last use >24 months
history of EEG or any electrical implant (i.e. pacemaker)
history of Parkinson's, diagnosis of bipolar, schizophrenia/schizo-affective d/o, OCD, epilepsy, alzheimers
primary drug of choice alcohol or marijuana
taking antipsychotic drugs

Where it is running

Allison J. Huff — Tucson, Arizona, United States (enrolling)

Full record on ClinicalTrials.gov

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