Clinical trial NCT05845164: tDCS and Impulsivity
Official title: Impulsivity Mediation Using Transcranial Direct Current Stimulation Paired With Acceptance Commitment Therapy as an Adjunctive Therapy for Substance Use Disorder
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Substance Use Disorders
Substance Abuse
Substance Use
Keywords: substance abuse
tDCS
substance use disorder
SUD
Lead sponsor: University of Arizona
Sponsor class: OTHER
First posted: 2023-05-06
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 79
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Intervention model description: 30 participants will be recruited and randomly placed in either the treatment or the sham group. The randomization ratio is 1:1. Each participant has an equal chance of being assigned to each condition and each participant will be assigned to a condition independently of the other participants. The sample is small (15 each group), so in order to ensure random assignment, we will assign a unique number to every participant of the study's sample. Then, we will use a lottery method to randomly assign each number to the control or experimental group.

Both the treatment and sham groups will participate in the ACT activity and the stop signal task which is administered at baseline and the final visit, but only the treatment group will receive tDCS.
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: The primary objective of the proposed study is to determine the impact of tDCS on impulsivity in SUD subjects. The long-term goal of the study is to address the underlying neurobiological deficiencies caused by SUD and provide a more personalized adjunctive SUD treatment.

Aim 1 will establish the extent of change to brain waves during tDCS+ACT treatment sessions in both arms while also performing the stop signal task. This aim will be achieved by capturing baseline EEG readings of the entire brain for subjects in both arms and also capturing EEG readings during the treatment phase and at the final study visit 1-week post and comparing between and within results.

Aim 2 will determine whether a change to self-reported impulsiveness occurs as a result of tDCS or tDCS and ACT exercise accompanied by the stop signal task. The investigators will achieve this aim by comparing the baseline Barratt Impulsiveness Scale (BIS-11) survey results of subjects in treatment and placebo arms to BIS-11 survey results on the final day of the 5 days of treatment and one week later, enabling investigators to determine any short-term change or durable change to impulsivity.

Aim 3 will measure whether the tDCS system, tKIWI, results in any unwanted side effects or adverse events. The investigators will achieve this aim by monitoring subjects' vitals during the entire session and evaluating results of a questionnaire after each treatment session and after the final study visit, enabling us to capture reported discomfort.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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

Primary outcomes:
measure: Difference in brain waves from before and after treatment measured by the EEG component of the tDCS device
timeFrame: 14 months
measure: Change in impulsivity from treatment using Barratt Impulsiveness Scale (BIS-11) survey
timeFrame: 14 months
measure: Side effects or adverse events from the study device using vitals signs (blood pressure, heart rate, and temperature).
timeFrame: 14 months
measure: Side effects or adverse events from the study device using a multiple choice side effect questionare
timeFrame: 14 months
Secondary outcomes:
Other outcomes:
Locations:
city: Tucson
country: United States
facility: Allison J. Huff
state: Arizona
Study officials:
affiliation: University of Arizona
name: Allison J Huff, DHEd
role: PRINCIPAL_INVESTIGATOR
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