Substance Use DisordersNCT05845164
tDCS and Impulsivity
A study testing tDCS in people with Substance Use Disorders and Substance Abuse, run by University of Arizona at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 79 years
- Conditions the study is for
- Substance Use Disorders, Substance Abuse, Substance Use
- What is being tested?
- tDCS
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jun 2023to 11 Oct 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 79 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 15Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Allison J. Huff
Tucson, Arizona, 85711
Allison J Huff, DHEd, 520-626-2719, allison7@arizona.edu
Todd W Vanderah, PhD, 520-626-7801, vanderah@arizona.edu
About this study
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.
Read the 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.
- Conditions
- Substance Use Disorders, Substance Abuse, Substance Use
- Being tested
- tDCS, tDCS Sham
- Keywords
- substance abuse, tDCS, substance use disorder, SUD
- Medical subject headings
- Substance-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
tDCSDevice
Also called tKIWI
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 ShamDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Treatment | Experimental | 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. Receives: Device: tDCS |
| Sham | Sham comparator | 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. Receives: Device: tDCS Sham |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 14 months
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.
Measured: 14 months
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.
Measured: 14 months
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.
Measured: 14 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2023
- Study start1 Jun 2023 (estimated)
- Primary completion1 Jul 2023 (estimated)
- Study completion11 Oct 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (34)Papers the sponsor has linked to this study.
- Other trials for Substance Use DisordersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- 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.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Arizona
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Allison J Huff Macpherson, University of Arizona
- Investigators
- Allison J Huff, DHEd, Principal investigator, University of Arizona
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05845164
- Sponsor's protocol ID
- STUDY00000768
- Status last verified
- May 2023
- First submitted
- 20 Jan 2023
- Last updated
- 6 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The deidentified raw data will be stored for future research. The results will be published and shared with the industry partner, ni20, inc.
Publications
Johnston LD, Miech RA, O'Malley PM, Bachman JG, Schulenberg JE, Patrick ME. Monitoring the Future National Survey Results on Drug Use, 1975-2020: Overview, Key Findings on Adolescent Drug Use. Institute for Social Research 2021
Drug Overdose Deaths: Drug Overdose Deaths Remain High: Centers for Disease Control and Prevention, 2019.
NIDA. 2020 JCJDRfhwdgpdc-jo, November 10. Criminal Justice DrugFacts: NIDA, 2020. 4. Painter JM, Malte CA, Rubinsky AD, et al. High inpatient utilization among Veterans Health
Painter JM, Malte CA, Rubinsky AD, Campellone TR, Gilmore AK, Baer JS, Hawkins EJ. High inpatient utilization among Veterans Health Administration patients with substance-use disorders and co-occurring mental health conditions. Am J Drug Alcohol Abuse. 2018;44(3):386-394. doi: 10.1080/00952990.2017.1381701. Epub 2017 Nov 2.
PubMed 29095057Holtzheimer PE, Mayberg HS. Neuromodulation for treatment-resistant depression. F1000 Med Rep. 2012;4:22. doi: 10.3410/M4-22. Epub 2012 Nov 1.
PubMed 23189091Arns M, Swatzyna RJ, Gunkelman J, Olbrich S. Sleep maintenance, spindling excessive beta and impulse control: an RDoC arousal and regulatory systems approach? Neuropsychiatric Electrophysiology 2015;1(1):5 doi: 10.1186/s40810-015-0005-9[published Online First: Epub Date]|.
Chen J, Qin J, He Q, Zou Z. A Meta-Analysis of Transcranial Direct Current Stimulation on Substance and Food Craving: What Effect Do Modulators Have? Front Psychiatry. 2020 Jun 26;11:598. doi: 10.3389/fpsyt.2020.00598. eCollection 2020.
PubMed 32670118Coles AS, Kozak K, George TP. A review of brain stimulation methods to treat substance use disorders. Am J Addict. 2018 Mar;27(2):71-91. doi: 10.1111/ajad.12674. Epub 2018 Feb 19.
PubMed 29457674Gilmore CS, Dickmann PJ, Nelson BG, Lamberty GJ, Lim KO. Transcranial Direct Current Stimulation (tDCS) paired with a decision-making task reduces risk-taking in a clinically impulsive sample. Brain Stimul. 2018 Mar-Apr;11(2):302-309. doi: 10.1016/j.brs.2017.11.011. Epub 2017 Nov 22.
PubMed 29174303Kwon YH, Kang KW, Lee NK, Son SM. Does hemispheric lateralization influence therapeutic effects of transcranial direct current stimulation? Neural Regen Res. 2016 Jan;11(1):126-9. doi: 10.4103/1673-5374.175057.
PubMed 26981100Lapenta OM, Marques LM, Rego GG, Comfort WE, Boggio PS. tDCS in Addiction and Impulse Control Disorders. J ECT. 2018 Sep;34(3):182-192. doi: 10.1097/YCT.0000000000000541.
PubMed 30095681Wang TR, Moosa S, Dallapiazza RF, Elias WJ, Lynch WJ. Deep brain stimulation for the treatment of drug addiction. Neurosurg Focus. 2018 Aug;45(2):E11. doi: 10.3171/2018.5.FOCUS18163.
PubMed 30064320McGovern MP, Carroll KM. Evidence-based practices for substance use disorders. Psychiatr Clin North Am. 2003 Dec;26(4):991-1010. doi: 10.1016/s0193-953x(03)00073-x.
PubMed 14711132Reese ED, Kane LF, Paquette CE, Frohlich F, Daughters SB. Lost in Translation: the Gap Between Neurobiological Mechanisms and Psychosocial Treatment Research for Substance Use Disorders. Curr Addict Rep. 2021 Sep;8(3):440-451. doi: 10.1007/s40429-021-00382-8. Epub 2021 Jul 7.
PubMed 40406375van der Stel J. Precision in Addiction Care: Does It Make a Difference? Yale J Biol Med. 2015 Nov 24;88(4):415-22. eCollection 2015 Dec.
PubMed 26604867
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impulsivity Mediation Using Transcranial Direct Current Stimulation Paired With Acceptance Commitment Therapy as an Adjunctive Therapy for Substance Use Disorder
- ClinicalTrials.gov ID
- NCT05845164
- Acronym / sponsor ID
- STUDY00000768
- Conditions
- Substance Use Disorders, Substance Abuse, Substance Use
- Keywords
- substance abuse, tDCS, substance use disorder, SUD
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- University of ArizonaUniversity, hospital or other
- Study start
- 1 Jun 2023 (estimated)
- Primary completion
- 1 Jul 2023 (estimated)
- Study completion
- 11 Oct 2023 (estimated)
- First posted
- 6 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind (participant)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Treatment | Experimental | Device: tDCSThe 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 | Sham comparator | Device: tDCS ShamThe 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. |
Who may qualify
- Ages
- 18 to 79 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (15 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| tDCSAlso: tKIWIEEG: 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. | Device | Treatment |
| tDCS ShamEEG: 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. | Device | Sham |
Primary outcome
Difference in brain waves from before and after treatment measured by the EEG component of the tDCS device
Time frame: 14 months
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.
Change in impulsivity from treatment using Barratt Impulsiveness Scale (BIS-11) survey
Time frame: 14 months
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.
Side effects or adverse events from the study device using vitals signs (blood pressure, heart rate, and temperature).
Time frame: 14 months
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.
Side effects or adverse events from the study device using a multiple choice side effect questionare
Time frame: 14 months
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2023.
- BackgroundJohnston LD, Miech RA, O'Malley PM, Bachman JG, Schulenberg JE, Patrick ME. Monitoring the Future National Survey Results on Drug Use, 1975-2020: Overview, Key Findings on Adolescent Drug Use. Institute for Social Research 2021
- BackgroundDrug Overdose Deaths: Drug Overdose Deaths Remain High: Centers for Disease Control and Prevention, 2019.
- BackgroundNIDA. 2020 JCJDRfhwdgpdc-jo, November 10. Criminal Justice DrugFacts: NIDA, 2020. 4. Painter JM, Malte CA, Rubinsky AD, et al. High inpatient utilization among Veterans Health
- Background: PubMed 29095057Painter JM, Malte CA, Rubinsky AD, Campellone TR, Gilmore AK, Baer JS, Hawkins EJ. High inpatient utilization among Veterans Health Administration patients with substance-use disorders and co-occurring mental health conditions. Am J Drug Alcohol Abuse. 2018;44(3):386-394. doi: 10.1080/00952990.2017.1381701. Epub 2017 Nov 2.
- Background: PubMed 23189091Holtzheimer PE, Mayberg HS. Neuromodulation for treatment-resistant depression. F1000 Med Rep. 2012;4:22. doi: 10.3410/M4-22. Epub 2012 Nov 1.
- BackgroundArns M, Swatzyna RJ, Gunkelman J, Olbrich S. Sleep maintenance, spindling excessive beta and impulse control: an RDoC arousal and regulatory systems approach? Neuropsychiatric Electrophysiology 2015;1(1):5 doi: 10.1186/s40810-015-0005-9[published Online First: Epub Date]|.
- Background: PubMed 32670118Chen J, Qin J, He Q, Zou Z. A Meta-Analysis of Transcranial Direct Current Stimulation on Substance and Food Craving: What Effect Do Modulators Have? Front Psychiatry. 2020 Jun 26;11:598. doi: 10.3389/fpsyt.2020.00598. eCollection 2020.
- Background: PubMed 29457674Coles AS, Kozak K, George TP. A review of brain stimulation methods to treat substance use disorders. Am J Addict. 2018 Mar;27(2):71-91. doi: 10.1111/ajad.12674. Epub 2018 Feb 19.
- Background: PubMed 29174303Gilmore CS, Dickmann PJ, Nelson BG, Lamberty GJ, Lim KO. Transcranial Direct Current Stimulation (tDCS) paired with a decision-making task reduces risk-taking in a clinically impulsive sample. Brain Stimul. 2018 Mar-Apr;11(2):302-309. doi: 10.1016/j.brs.2017.11.011. Epub 2017 Nov 22.
- Background: PubMed 26981100Kwon YH, Kang KW, Lee NK, Son SM. Does hemispheric lateralization influence therapeutic effects of transcranial direct current stimulation? Neural Regen Res. 2016 Jan;11(1):126-9. doi: 10.4103/1673-5374.175057.
- Background: PubMed 30095681Lapenta OM, Marques LM, Rego GG, Comfort WE, Boggio PS. tDCS in Addiction and Impulse Control Disorders. J ECT. 2018 Sep;34(3):182-192. doi: 10.1097/YCT.0000000000000541.
- Background: PubMed 30064320Wang TR, Moosa S, Dallapiazza RF, Elias WJ, Lynch WJ. Deep brain stimulation for the treatment of drug addiction. Neurosurg Focus. 2018 Aug;45(2):E11. doi: 10.3171/2018.5.FOCUS18163.
- Stop Signal taskLink provided by the sponsor.
- Stop Signal Task informationLink provided by the sponsor.
- Individual participant dataSharing planned: No. The deidentified raw data will be stored for future research. The results will be published and shared with the industry partner, ni20, inc.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Allison J Huff, DHEd principal investigator
University of Arizona
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing tDCS in people with Substance Use Disorders and Substance Abuse, run by University of Arizona at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 6 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Allison J Huff, DHEd (520-626-2719, allison7@arizona.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the 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). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05845164, which also lists 34 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 May 2023.