Recruiting

tDCS & Impulsivity

Sponsor:

University of Arizona

Code:

NCT05845164

Conditions

Substance Use Disorders

Substance Abuse

Substance Use

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

tDCS

tDCS Sham

Study Details

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.

Conditions

Substance Use Disorders

Substance Abuse

Substance Use

Study ID

NCT05845164

Start date

Jun 1, 2023

Status verified date

May, 2023

Completion date

Oct 11, 2023

Anticipated

Primary completion date

Jul 1, 2023

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

30 participants

Anticipated

Allocation

Randomized

Intervention Model

Factorial

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Treatment

The anode and cathode are two large 5 cm by 5 cm gel-based pads which are placed on the scalp. Current that flows from the cathode to the anode has an inhibitory effect on the stimulated area, while current that flows from the anode to the cathode is typically excitatory.

In order to help minimize the stinging feel of the treatment, we have chosen to ramp up time and frequency. For visits 2-6 (tDCS treatment visits), we will start with 0.5mA ramping up to 0.75mA for 5 minutes. Followed by a brief (8 sec) EEG recording. Then, we will apply 0.75mA to 1mA while watching the ACT video for 5 minutes. This will also be followed by 8 second EEG recording. The final application of current will be 1.0mA to 1.75mA for 10 minutes followed again by 8 second EEG recording.

sham comparator: Sham

The sham group will receive ramped up current from 0.0mA not to exceed 0.5mA for the first minute at the initiation of each of the three "ramp-ups," after which the current will be turned off. This is to maintain a blind trial. 0.5mA is negligible current but mimics treatment with an initial small tingle. The current delivered by tDCS is not strong enough to trigger an action potential in a neuron; instead its "sub-threshold" changes the pattern of already active neurons.

Interventions

tDCS

EEG: The tKIWI uses sensors placed on specific locations of the head for the EEG reading.

tDCS: The anode and cathode are two large 5 cm by 5 cm gel-based pads which are placed on the scalp. This reduces the risk of burn or irritation and increases conduction. The 2 electrodes are connected to the tKIWI device which delivers a low intensity electrical current (</=2A), thereby polarizing membrane potential of neurons in the stimulated area. Current that flows from the cathode to the anode has an inhibitory effect on the stimulated area, while current that flows from the anode to the cathode is typically excitatory. We will be initiating bilateral stimulation of the Dorsolateral pre-frontal cortex (DLPFC), which has been shown in the literature to elicit a significant decrease in ambiguous risk-taking behavior in healthy human subjects and a decrease in impulsivity on a non-ambiguous risk task.

tDCS Sham

EEG: The tKIWI uses sensors placed on specific locations of the head for the EEG reading.

The sham group will receive ramped up current from 0.0mA to no more than 0.5mA for the first minute at the initiation of each of the three "ramp ups," after which the current will be turned off. This is to maintain a blind trial. 0.5mA is negligible current, but mimics treatment with an initial small tingle. The current delivered by tDCS is not strong enough to trigger an action potential in a neuron; instead its "sub-threshold" changes the pattern of already active neurons.

Primary outcome measure

  • Difference in brain waves from before and after treatment measured by the EEG component of the tDCS device [ Time Frame: 14 months ]
  • Change in impulsivity from treatment using Barratt Impulsiveness Scale (BIS-11) survey [ Time Frame: 14 months ]
  • Side effects or adverse events from the study device using vitals signs (blood pressure, heart rate, and temperature). [ Time Frame: 14 months ]
  • Side effects or adverse events from the study device using a multiple choice side effect questionare [ Time Frame: 14 months ]

Central Contacts and Locations

Central contacts

Allison J Huff, DHEd

520-626-2719allison7@arizona.edu

Leena F Idris, BS

5202474415idris1@arizona.edu

Locations

Allison J. Huff

Recruiting

Tucson, Arizona, United States, 85711

Contacts

Allison J Huff, DHEd

520-626-2719allison7@arizona.edu

Todd W Vanderah, PhD

520-626-7801vanderah@arizona.edu

More Information

Sponsor

University of Arizona

Last update posted

May 6, 2023

Last verified

May, 2023

Keywords

  • substance abuse
  • tDCS
  • substance use disorder
  • SUD

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Arizona on 2023-05-06.