Substance Use Disorders Clinical Trial
Official title:
Impulsivity Mediation Using Transcranial Direct Current Stimulation Paired With Acceptance Commitment Therapy as an Adjunctive Therapy for Substance Use Disorder
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.
Status | Recruiting |
Enrollment | 30 |
Est. completion date | October 11, 2023 |
Est. primary completion date | July 1, 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 79 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
United States | Allison J. Huff | Tucson | Arizona |
Lead Sponsor | Collaborator |
---|---|
University of Arizona |
United States,
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* Note: There are 34 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Difference in brain waves from before and after treatment measured by the EEG component of the tDCS device | Will measure the change in brain waves during tDCS+ACT treatment sessions in both arms. 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 treatment phase and at final study visit 1 week post and comparing between and within results. | 14 months | |
Primary | Change in impulsivity from treatment using Barratt Impulsiveness Scale (BIS-11) survey | 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. BIS-11 survey is a 30 question survey to measure impulsiveness. The answers to the questions are ranked on a scale of 1 to 4, 1 being never/ unlikely and 4 being almost always/ always. The tally of all questions is collected, and the points range from 30 to 120, the higher the score the higher level of impulsiveness. | 14 months | |
Primary | Side effects or adverse events from the study device using vitals signs (blood pressure, heart rate, and temperature). | Will measure whether the tDCS system, tKIWI, results in any unwanted side effects or adverse events. We will achieve this aim by monitoring subjects' vitals during the entire session (blood pressure, heart rate, and temperature), enabling investigators to capture reported discomfort. | 14 months | |
Primary | Side effects or adverse events from the study device using a multiple choice side effect questionare | A multiple choice side effect survey will be given to all participants during study visits 1 through 5. The questions ask about possible side effects such as pain, redness, and tingling. If the participant answers yes they experienced the side effect, they are asked to rank it (barley, a little, very) and the duration of the side effect (continued after treatment, stopped when treatment stopped, stopped during treatment). This will be used to asses risk and side effects of the device. | 14 months |
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