Alcohol Use DisorderNCT06060496
Theta Burst Stimulation for Alcohol Use Disorder
A study testing Active cTBS in people with Alcohol Use Disorder, run by Gopalkumar Rakesh at 1 site in United States.
Trial summary
The study will examine the effects of two continuous theta burst stimulation (cTBS) sessions (given in a single day) on resting state functional MRI (fMRI), alcohol cue related attentional bias and alcohol craving in patients with alcohol use disorder (AUD). Read more about this study
- Who is it for?
- Ages 21 to 60 years
- Conditions the study is for
- Alcohol Use Disorder
- What is being tested?
- Active cTBS
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 8 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Oct 2023to 17 Apr 2024
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 21 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Patients seen at a clinic within the University of Kentucky Healthcare
- 21-60 years of age
- male or female gender
- Able to read, understand and communicate in English
- willing to adhere to the general rules of the UK Healthcare
- Must fulfill criteria for moderate alcohol use disorder.
Who cannot join
- Positive pregnancy test for females
- traumatic brain injury, history of seizure disorder, history of or current diagnosis of schizophrenia
- intracranial metal shrapnel
- previous adverse effect with TMS
- sub-threshold consistency while performing behavioral tasks
- failure to show baseline attentional bias to alcohol versus neutral cues.
Trial locations and contacts
1 site in 1 country.
About this study
The study will examine the effects of two continuous theta burst stimulation (cTBS) sessions (given in a single day) on resting state functional MRI (fMRI), alcohol cue related attentional bias and alcohol craving in patients with alcohol use disorder (AUD).
Read the detailed description
Although pharmacotherapy and behavioral treatments have been approved for AUD, their effects sizes are modest. Noninvasive neuromodulation like Transcranial magnetic stimulation (TMS) can offer an alternative treatment option for AUD. TMS is a method of noninvasive neuromodulation that utilizes a magnetic field to focal electrical current in the brain. When these electrical currents are focused on specific brain regions, pertinent to the neurobiology of AUD it leads to modulation of behavior and plausibly decrease in alcohol craving and use. Previous TMS studies have used heterogenous parameters, including frequencies ranging from 1 Hz to 20 Hz. Regions targeted by these studies encompassed ventromedial prefrontal cortex, left dorsolateral prefrontal cortex (left dlPFC) and right dorsolateral prefrontal cortex. Two studies used a TMS paradigm with greater efficiency than other routine TMS paradigms, called continuous theta burst stimulation. These studies delivered 3600 pulses of cTBS to the left frontal pole/ventromedial prefrontal cortex and showed significant reduction in alcohol cue reactivity and corroborative changes in both resting state and task based functional connectivity. Of these two studies, one was notable in comparing active cTBS (3600 pulses per session, one session every day for ten days over two weeks) versus sham cTBS. A deep TMS (dTMS) study that compared dTMS (15 sessions, five sessions every week for three weeks) to sham dTMS using an H7 coil (targeting medial prefrontal and anterior cingulate cortices). This study showed decreased craving after treatment and percentage of heavy drinking days in the active versus sham control group. Active dTMS was associated with decreased resting-state functional connectivity of the dorsal anterior cingulate cortex with the caudate nucleus and decreased connectivity of the medial prefrontal cortex to the subgenual anterior cingulate cortex. No study has done multiple sessions of cTBS in a single day. In addition, no study has previously delivered cTBS to the left dlPFC, to modulate alcohol craving and alcohol cue based attentional bias.
- Conditions
- Alcohol Use Disorder
- Being tested
- Active cTBS, Sham cTBS
- Keywords
- Transcranial magnetic stimulation (TMS)
- Medical subject headings
- Alcoholism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Active cTBSDevice
Also called Continuous theta burst stimulation
Two cTBS sessions (each session delivering 3600 pulses) separated by 50 minutes
Sham cTBSDevice
Also called Continuous theta burst stimulation
Two sham cTBS sessions (sham mimics the experimental session but does not deliver any electricity to the brain) separated by 50 minutes
| Study group | Role | What they receive |
|---|---|---|
| Active cTBS and sham cTBS | Experimental | There is only one arm in this study and all participants in this arm will receive 2 interventions: active and sham cTBS in a within subject blinded fashion. They will first receive active cTBS and then sham cTBS, separated by four weeks to minimize carryover effects. Receives: Device: Active cTBS; Device: Sham cTBS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Penn Alcohol Craving Scale
Craving measured using the Penn alcohol craving scale (PACS) that has five items and is rated on a scale of 1 to 6. Minimum score is 1 and maximum score is 30. Higher score equates to increased craving
Measured: Before and after two cTBS sessions, approximately 2 hours
Change in Alcohol Cue Attentional Bias
Fixation time on alcohol cues measured using an eye tracker in milliseconds. Higher score indicates greater attentional bias.
Measured: Before and after two cTBS sessions, approximately 2 hours
Secondary outcomes (1)
Resting State Functional Connectivity
Number of participants with resting state functional connectivity scans acquired before and after cTBS and sham cTBS
Measured: Before and after two cTBS sessions, approximately 2 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2023
- Study start1 Oct 2023
- Primary completion17 Apr 2024
- Study completion17 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Alcohol Use DisorderStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gopalkumar Rakesh
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor-investigator, Gopalkumar Rakesh, University of Kentucky
- Investigators
- Gopalkumar Rakesh, PhD, Principal investigator, University of Kentucky
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06060496
- Sponsor's protocol ID
- 86853
- Other IDs
- 2P30CA177558-11
- Status last verified
- Apr 2025
- First submitted
- 22 Sep 2023
- Last updated
- 6 May 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Theta Burst Stimulation for Alcohol Use Disorder
- ClinicalTrials.gov ID
- NCT06060496
- Acronym / sponsor ID
- 86853
- Conditions
- Alcohol Use Disorder
- Keywords
- Transcranial magnetic stimulation (TMS)
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Gopalkumar RakeshUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 1 Oct 2023 (actual)
- Primary completion
- 17 Apr 2024 (actual)
- Study completion
- 17 Apr 2024 (actual)
- First posted
- 29 Sep 2023 (actual)
- Results
- Posted 6 May 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The study will examine the effects of two continuous theta burst stimulation (cTBS) sessions (given in a single day) on resting state functional MRI (fMRI), alcohol cue related attentional bias and alcohol craving in patients with alcohol use disorder (AUD).
Detailed description
Although pharmacotherapy and behavioral treatments have been approved for AUD, their effects sizes are modest. Noninvasive neuromodulation like Transcranial magnetic stimulation (TMS) can offer an alternative treatment option for AUD. TMS is a method of noninvasive neuromodulation that utilizes a magnetic field to focal electrical current in the brain. When these electrical currents are focused on specific brain regions, pertinent to the neurobiology of AUD it leads to modulation of behavior and plausibly decrease in alcohol craving and use. Previous TMS studies have used heterogenous parameters, including frequencies ranging from 1 Hz to 20 Hz. Regions targeted by these studies encompassed ventromedial prefrontal cortex, left dorsolateral prefrontal cortex (left dlPFC) and right dorsolateral prefrontal cortex. Two studies used a TMS paradigm with greater efficiency than other routine TMS paradigms, called continuous theta burst stimulation. These studies delivered 3600 pulses of cTBS to the left frontal pole/ventromedial prefrontal cortex and showed significant reduction in alcohol cue reactivity and corroborative changes in both resting state and task based functional connectivity. Of these two studies, one was notable in comparing active cTBS (3600 pulses per session, one session every day for ten days over two weeks) versus sham cTBS. A deep TMS (dTMS) study that compared dTMS (15 sessions, five sessions every week for three weeks) to sham dTMS using an H7 coil (targeting medial prefrontal and anterior cingulate cortices). This study showed decreased craving after treatment and percentage of heavy drinking days in the active versus sham control group. Active dTMS was associated with decreased resting-state functional connectivity of the dorsal anterior cingulate cortex with the caudate nucleus and decreased connectivity of the medial prefrontal cortex to the subgenual anterior cingulate cortex. No study has done multiple sessions of cTBS in a single day. In addition, no study has previously delivered cTBS to the left dlPFC, to modulate alcohol craving and alcohol cue based attentional bias.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Active cTBS and sham cTBS | Experimental | Device: Active cTBS, Device: Sham cTBSThere is only one arm in this study and all participants in this arm will receive 2 interventions: active and sham cTBS in a within subject blinded fashion. They will first receive active cTBS and then sham cTBS, separated by four weeks to minimize carryover effects. |
Who may qualify
- Ages
- 21 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Patients seen at a clinic within the University of Kentucky Healthcare
- 21-60 years of age
- male or female gender
- Able to read, understand and communicate in English
- willing to adhere to the general rules of the UK Healthcare
Key exclusion criteria (6 listed)
- Positive pregnancy test for females
- traumatic brain injury, history of seizure disorder, history of or current diagnosis of schizophrenia
- intracranial metal shrapnel
- previous adverse effect with TMS
- sub-threshold consistency while performing behavioral tasks
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 |
|---|---|---|
| Active cTBSAlso: Continuous theta burst stimulationTwo cTBS sessions (each session delivering 3600 pulses) separated by 50 minutes | Device | Active cTBS and sham cTBS |
| Sham cTBSAlso: Continuous theta burst stimulationTwo sham cTBS sessions (sham mimics the experimental session but does not deliver any electricity to the brain) separated by 50 minutes | Device | Active cTBS and sham cTBS |
Primary outcome
Change in Penn Alcohol Craving Scale
Time frame: Before and after two cTBS sessions, approximately 2 hours
Craving measured using the Penn alcohol craving scale (PACS) that has five items and is rated on a scale of 1 to 6. Minimum score is 1 and maximum score is 30. Higher score equates to increased craving
Change in Alcohol Cue Attentional Bias
Time frame: Before and after two cTBS sessions, approximately 2 hours
Fixation time on alcohol cues measured using an eye tracker in milliseconds. Higher score indicates greater attentional bias.
1 secondary outcome
Resting State Functional Connectivity
Time frame: Before and after two cTBS sessions, approximately 2 hours
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Gopalkumar Rakesh, PhD principal investigator
University of Kentucky
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Active cTBS in people with Alcohol Use Disorder, run by Gopalkumar Rakesh 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 6 inclusion and 6 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: finished, as of the sponsor's last update on 6 May 2025. 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. 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?
Yes. Results are posted in the registry (first posted 6 May 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Penn Alcohol Craving Scale (time frame: Before and after two cTBS sessions, approximately 2 hours). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 2025.