Cocaine Use DisorderNCT05986578
Identifying Electrophysiological Targets for Transcranial Magnetic Stimulation in Cocaine Use Disorder
A study testing TMS to dmPFC and TMS to dlPFC in people with Cocaine Use Disorder, run by The University of Texas Health Science Center, Houston at 1 site in United States.
Trial summary
The purpose of this study is to assess effects of intermittent theta burst stimulation (iTBS) to left dorsolateral prefrontal cortex (dlPFC) and dorsomedial prefrontal cortex (dmPFC) compared to sham on electrophysiological indices of reward sensitivity and motivated attention in adults with cocaine use disorder. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Cocaine Use Disorder
- What is being tested?
- TMS to dmPFC and TMS to dlPFC
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 75 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Nov 2024to 30 Jun 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- non-treatment-seeking adults
- meet Diagnostic and Statistical Manual of Mental Disorders (DSM)-5 criteria for current cocaine use disorder of at least moderate severity (≥ 4 symptoms)
- have at least 1 positive urine Benzoylecgonine (BE) specimen (≥ 300 ng/mL) during intake
- be able to understand the consent form and provide written informed consent
- be able to provide the following verifiable information for a minimum of 2 contact persons: full legal name,email address, local mailing address, and as applicable, home, work, and cell phone numbers
Who cannot join
- current DSM-5 diagnosis for substance use disorder (of at least moderate severity) other than cocaine, marijuana, or nicotine
- in the opinion of the principal investigator (PI), the presence of any medical, neurological, psychiatric, or physical condition, disease, or illness that, may: (a) compromise interfere, limit, effect or reduce the subject's ability to complete the study; or (b) adversely impact the safety of the subject or the integrity of the data
- has current or recent (within 3 months of potential enrollment) suicidal ideation, suicidal behavior, homicidal ideation or a homicidal plan sufficient to raise subject safety concerns based on the following assessments according to the PI:
- Structured Clinical Interview for DSM-5 (SCID-5)
- Columbia Suicide Severity Rating Scale (C-SSRS) Screener - Answers YES to Questions 3, 4, 5, or 6
- Assault \& Homicidal Danger Assessment Tool - Key to Danger > 1
Show all 35Show fewer
- medical implants contraindicating TMS (i.e., aneurysm clips or coils, stents, implanted stimulators, implanted vagus nerve or deep brain stimulators, implanted electrical devices such as pacemakers or medication pumps electrodes for monitoring brain activity, cochlear implants for hearing, any magnetic implants, bullet fragments, any other metal device or object implanted in your body closer than 30 cm from the coil)
- history of brain surgery
- history of an intracranial lesion or any medical or neurological diagnosis/condition associated with increased intracranial pressure (i.e., Idiopathic Intracranial Hypertension/Pseudotumor Cerebri) OR any of the following symptoms within 30 days of enrollment: headaches > 15 days/month, loss of vision or decreased vision
- moderate-to-severe heart disease
- history of stroke
- is taking any antidepressant or antipsychotic medication at a dose above the maximum recommended dose or at a dose deemed to be potentially unsafe according to the PI; has taken any of the following medications, which are known to increase the risk of seizures, within 1 week of study enrollment; or does not agree to abstain from taking the following medications during study participation:
- clozapine137
- chlorpromazine137
- bupropion
- clomipramine hydrochloride
- amoxapine
- maprotiline hydrochloride
- diphenhydramine
- stimulants other than cocaine including the following:
- Dextroamphetamine and amphetamine
- Dextroamphetamine
- Lisdexamfetamine dimesylate
- Methamphetamine
- Methylphenidate
- tramadol
- isoniazid
- having conditions of probation or parole requiring reports of drug use to officers of the court
- personal history of epilepsy or seizure disorder and/or family history including a first-degree relative
- serious head injury with loss of consciousness
- impending incarceration
- pregnant or nursing for female patients
- inability to read, write, or speak English
- for adolescent aged participants (18-21 only): any risk factor for neurocardiogenic syncope (history of syncope/presyncope related to noxious stimuli, anxiety, micturition, or posture)
- hair style that is incompatible with EEG nets
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
The University of Texas Health Science Center at Houston
Houston, Texas, 77030
Heather Webber, PhD, 713-486-2723, Heather.E.Webber@uth.tmc.edu
Jessica Vincent, 713-486-2645, Jessica.N.Vincent@uth.tmc.edu
About this study
The purpose of this study is to assess effects of intermittent theta burst stimulation (iTBS) to left dorsolateral prefrontal cortex (dlPFC) and dorsomedial prefrontal cortex (dmPFC) compared to sham on electrophysiological indices of reward sensitivity and motivated attention in adults with cocaine use disorder.
- Conditions
- Cocaine Use Disorder
- Being tested
- TMS to dmPFC, TMS to dlPFC, Sham iTBS
- Keywords
- Transcranial Magnetic Stimulation (TMS), Event-Related Potentials, Substance Use Disorder, Reward Positivity, Late Positive Potential
- 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.
TMS to dmPFCDevice
TMS will be delivered with a MagVenture Mag Pro R30 with the Cool-B70 A/P coil with active liquid cooling and active/sham sides. For dmPFC, approximately 25% of the nasion-inion distance or Talairah coordinates X 0 Y+60 Z+60 will be measured. The first session will begin with the acquisition of the resting motor threshold (rMT) on the contralateral hand. iTBS (triplet 50 Hz bursts, repeated at 5 Hz, 2 sec on and 8 sec off; 600 pulses per session) will be delivered at 110% of the rMT and will last ~3 minutes. The stimulation will start at a lower percentage and ramp up over time to acclimate participant to the feeling of stimulation. The intensity will be lowered in participant cannot tolerate the stimulation. Each participant will receive 3 sessions per visit with a 15-20 minute interval between sessions to increase the likelihood of detecting acute effects.
TMS to dlPFCDevice
TMS will be delivered with a MagVenture Mag Pro R30 with the Cool-B70 A/P coil with active liquid cooling and active/sham sides. For dlPFC, position F3 will be measured, using probabilistic EEG placement. The first session will begin with the acquisition of the resting motor threshold on the contralateral hand. iTBS (triplet 50 Hz bursts, repeated at 5 Hz, 2 sec on and 8 sec off; 600 pulses per session) will be delivered at 110% of the rMT and will last 3 minutes. The stimulation will start at a lower percentage and ramp up over time to acclimate participant to the feeling of stimulation. The intensity will be lowered in participant cannot tolerate the stimulation. Each participant will receive 3 sessions per visit with a 15-20 minute interval between sessions to increase the likelihood of detecting acute effects.
Sham iTBSDevice
Sham TMS will be delivered with the sham side of the MagVenture Cool B70 A/P coil. The software will be pre-programmed by a staff member that will not be involved in data analysis or collection for blinding purposes. The sham stimulation will match the number of pulses and length of time as the active condition and each participant will receive 3 sessions with a 15-20 min interval between sessions.
| Study group | Role | What they receive |
|---|---|---|
| dlPFC then dmPFC then Sham iTBS | Experimental | Not described Receives: Device: TMS to dmPFC; Device: TMS to dlPFC; Device: Sham iTBS |
| dmPFC then dlPFC then sham iTBS | Experimental | Not described Receives: Device: TMS to dmPFC; Device: TMS to dlPFC; Device: Sham iTBS |
| dmPFC then sham iTBS then dlPFC | Experimental | Not described Receives: Device: TMS to dmPFC; Device: TMS to dlPFC; Device: Sham iTBS |
| dlPFC then sham iTBS then dmPFC | Experimental | Not described Receives: Device: TMS to dmPFC; Device: TMS to dlPFC; Device: Sham iTBS |
| sham iTBS then dlPFC then dmPFC | Experimental | Not described Receives: Device: TMS to dmPFC; Device: TMS to dlPFC; Device: Sham iTBS |
| shami iTBS then dmPFC then dl PFC | Experimental | Not described Receives: Device: TMS to dmPFC; Device: TMS to dlPFC; Device: Sham iTBS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in the amplitude of the Reward Positivity (RewP) component in microvolts in response to feedback on the Doors Task
The Doors Task will be used to elicit the RewP component, representing reward sensitivity. The task is a guessing game, where participants guess which door contains a reward behind it. After selecting a door, the participants are notified if they found the prize by a green arrow pointing up or if they did not find the prize by a red arrow pointing down.
Measured: Baseline(before iTBS session),immediately after iTBS session
Change in the amplitude of the Late Positive Potential (LPP) in microvolts in response to visual stimuli on the Picture Viewing Task.
The Picture Viewing Task will be used to elicit the LPP, reflecting the motivational salience of a stimulus. During this task, participants are asked to view a slide show of images including pleasant, unpleasant, neutral, and cocaine-related images.
Measured: Baseline(before iTBS session),immediately after iTBS session
Secondary outcomes (5)
Change in craving as assessed by the Minnesota Cocaine Craving Scale (MCCS)
The intensity of craving score will be used, scored from 1(none at all) to 10 (a great deal).
Measured: Baseline(before iTBS session),immediately after iTBS session
Change in pain as assessed by the Visual Analogue Scale
This is scored from 1(no pain) to 10 (worst pain)
Measured: Baseline(before iTBS session),immediately after iTBS session
Change in cognitive function as assessed by the The Montreal Cognitive Assessment (MoCA)
Total score on the Montreal Cognitive Assessment (MoCA) range from 0 to 30, with a higher score indicating a better outcome.
Measured: Baseline(before iTBS session),immediately after iTBS session
Change in behavioral reward learning as assessed by the Pavlovian Go/No-Go task
In the first "learning" phase, participants learn whether to press a button or withhold a response to receive a monetary reward or avoid a loss. In the second "transfer" phase, participants perform a forced choice task, where each of the predictive cues in the learning phase are paired with each other. Participants must select the "most rewarding" cue.
Measured: Baseline(before iTBS session),immediately after iTBS session
Change in Anhedonia as assessed by the Snaith Hamilton Pleasure Scale (SHAPS)
This is a 14 item questionnaire. 9 of the questions are scored from 0(strongly disagree) to 3( strongly agree) and the rest are reverse coded with answer choices as follows: definitely agree, agree, disagree, and strongly disagree. Final scores range from 0-14 and higher score indicates worse outcome.
Measured: Baseline(before iTBS session),immediately after iTBS session
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2023
- Study start8 Nov 2024
- Primary completion30 Jun 2028 (estimated)
- Study completion30 Jun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cocaine Use DisorderStudies of the same condition, open and under way.
- More trials run by The University of Texas Health Science Center, HoustonThe sponsor's other registered studies.
- 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 75 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Responsible party
- Principal investigator, Heather E. Webber, PhD, The University of Texas Health Science Center, Houston
- Investigators
- Heather Webber, PhD, Principal investigator, The University of Texas Health Science Center, Houston
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05986578
- Sponsor's protocol ID
- HSC-MS-21-0813 (Main study)
- Other IDs
- K01DA058765
- Status last verified
- May 2025
- First submitted
- 3 Aug 2023
- Last updated
- 8 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Identifying Electrophysiological Targets for Transcranial Magnetic Stimulation in Cocaine Use Disorder
- ClinicalTrials.gov ID
- NCT05986578
- Acronym / sponsor ID
- HSC-MS-21-0813 (Main study)
- Conditions
- Cocaine Use Disorder
- Keywords
- Transcranial Magnetic Stimulation (TMS), Event-Related Potentials, Substance Use Disorder, Reward Positivity, Late Positive Potential
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 75 participants (estimated)
- Lead sponsor
- The University of Texas Health Science Center, HoustonUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- 8 Nov 2024 (actual)
- Primary completion
- 30 Jun 2028 (estimated)
- Study completion
- 30 Jun 2028 (estimated)
- First posted
- 14 Aug 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.
The purpose of this study is to assess effects of intermittent theta burst stimulation (iTBS) to left dorsolateral prefrontal cortex (dlPFC) and dorsomedial prefrontal cortex (dmPFC) compared to sham on electrophysiological indices of reward sensitivity and motivated attention in adults with cocaine use disorder.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| dlPFC then dmPFC then Sham iTBS | Experimental | Device: TMS to dmPFC, Device: TMS to dlPFC, Device: Sham iTBS |
| dmPFC then dlPFC then sham iTBS | Experimental | Device: TMS to dmPFC, Device: TMS to dlPFC, Device: Sham iTBS |
| dmPFC then sham iTBS then dlPFC | Experimental | Device: TMS to dmPFC, Device: TMS to dlPFC, Device: Sham iTBS |
| dlPFC then sham iTBS then dmPFC | Experimental | Device: TMS to dmPFC, Device: TMS to dlPFC, Device: Sham iTBS |
| sham iTBS then dlPFC then dmPFC | Experimental | Device: TMS to dmPFC, Device: TMS to dlPFC, Device: Sham iTBS |
| shami iTBS then dmPFC then dl PFC | Experimental | Device: TMS to dmPFC, Device: TMS to dlPFC, Device: Sham iTBS |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- non-treatment-seeking adults
- meet Diagnostic and Statistical Manual of Mental Disorders (DSM)-5 criteria for current cocaine use disorder of at least moderate severity (≥ 4 symptoms)
- have at least 1 positive urine Benzoylecgonine (BE) specimen (≥ 300 ng/mL) during intake
- be able to understand the consent form and provide written informed consent
- be able to provide the following verifiable information for a minimum of 2 contact persons: full legal name,email address, local mailing address, and as applicable, home, work, and cell phone numbers
Key exclusion criteria (35 listed)
- current DSM-5 diagnosis for substance use disorder (of at least moderate severity) other than cocaine, marijuana, or nicotine
- in the opinion of the principal investigator (PI), the presence of any medical, neurological, psychiatric, or physical condition, disease, or illness that, may: (a) compromise interfere, limit, effect or reduce the subject's ability to complete the study; or (b) adversely impact the safety of the subject or the integrity of the data
- has current or recent (within 3 months of potential enrollment) suicidal ideation, suicidal behavior, homicidal ideation or a homicidal plan sufficient to raise subject safety concerns based on the following assessments according to the PI:
- medical implants contraindicating TMS (i.e., aneurysm clips or coils, stents, implanted stimulators, implanted vagus nerve or deep brain stimulators, implanted electrical devices such as pacemakers or medication pumps electrodes for monitoring brain activity, cochlear implants for hearing, any magnetic implants, bullet fragments, any other metal device or object implanted in your body closer than 30 cm from the coil)
- history of brain surgery
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 |
|---|---|---|
| TMS to dmPFCTMS will be delivered with a MagVenture Mag Pro R30 with the Cool-B70 A/P coil with active liquid cooling and active/sham sides. For dmPFC, approximately 25% of the nasion-inion distance or Talairah coordinates X 0 Y+60 Z+60 will be measured. The first session will begin with the acquisition of the resting motor threshold (rMT) on the contralateral hand. iTBS (triplet 50 Hz bursts, repeated at 5 Hz, 2 sec on and 8 sec off; 600 pulses per session) will be delivered at 110% of the rMT and will last ~3 minutes. The stimulation will start at a lower percentage and ramp up over time to acclimate participant to the feeling of stimulation. The intensity will be lowered in participant cannot tolerate the stimulation. Each participant will receive 3 sessions per visit with a 15-20 minute interval between sessions to increase the likelihood of detecting acute effects. | Device | dlPFC then dmPFC then Sham iTBS, dlPFC then sham iTBS then dmPFC, dmPFC then dlPFC then sham iTBS, dmPFC then sham iTBS then dlPFC, sham iTBS then dlPFC then dmPFC, shami iTBS then dmPFC then dl PFC |
| TMS to dlPFCTMS will be delivered with a MagVenture Mag Pro R30 with the Cool-B70 A/P coil with active liquid cooling and active/sham sides. For dlPFC, position F3 will be measured, using probabilistic EEG placement. The first session will begin with the acquisition of the resting motor threshold on the contralateral hand. iTBS (triplet 50 Hz bursts, repeated at 5 Hz, 2 sec on and 8 sec off; 600 pulses per session) will be delivered at 110% of the rMT and will last 3 minutes. The stimulation will start at a lower percentage and ramp up over time to acclimate participant to the feeling of stimulation. The intensity will be lowered in participant cannot tolerate the stimulation. Each participant will receive 3 sessions per visit with a 15-20 minute interval between sessions to increase the likelihood of detecting acute effects. | Device | dlPFC then dmPFC then Sham iTBS, dlPFC then sham iTBS then dmPFC, dmPFC then dlPFC then sham iTBS, dmPFC then sham iTBS then dlPFC, sham iTBS then dlPFC then dmPFC, shami iTBS then dmPFC then dl PFC |
| Sham iTBSSham TMS will be delivered with the sham side of the MagVenture Cool B70 A/P coil. The software will be pre-programmed by a staff member that will not be involved in data analysis or collection for blinding purposes. The sham stimulation will match the number of pulses and length of time as the active condition and each participant will receive 3 sessions with a 15-20 min interval between sessions. | Device | dlPFC then dmPFC then Sham iTBS, dlPFC then sham iTBS then dmPFC, dmPFC then dlPFC then sham iTBS, dmPFC then sham iTBS then dlPFC, sham iTBS then dlPFC then dmPFC, shami iTBS then dmPFC then dl PFC |
Primary outcome
Change in the amplitude of the Reward Positivity (RewP) component in microvolts in response to feedback on the Doors Task
Time frame: Baseline(before iTBS session),immediately after iTBS session
The Doors Task will be used to elicit the RewP component, representing reward sensitivity. The task is a guessing game, where participants guess which door contains a reward behind it. After selecting a door, the participants are notified if they found the prize by a green arrow pointing up or if they did not find the prize by a red arrow pointing down.
Change in the amplitude of the Late Positive Potential (LPP) in microvolts in response to visual stimuli on the Picture Viewing Task.
Time frame: Baseline(before iTBS session),immediately after iTBS session
The Picture Viewing Task will be used to elicit the LPP, reflecting the motivational salience of a stimulus. During this task, participants are asked to view a slide show of images including pleasant, unpleasant, neutral, and cocaine-related images.
5 secondary outcomes
Change in craving as assessed by the Minnesota Cocaine Craving Scale (MCCS)
Time frame: Baseline(before iTBS session),immediately after iTBS session
Change in pain as assessed by the Visual Analogue Scale
Time frame: Baseline(before iTBS session),immediately after iTBS session
Change in cognitive function as assessed by the The Montreal Cognitive Assessment (MoCA)
Time frame: Baseline(before iTBS session),immediately after iTBS session
Change in behavioral reward learning as assessed by the Pavlovian Go/No-Go task
Time frame: Baseline(before iTBS session),immediately after iTBS session
Change in Anhedonia as assessed by the Snaith Hamilton Pleasure Scale (SHAPS)
Time frame: Baseline(before iTBS session),immediately after iTBS session
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2025.
- Individual participant dataSharing planned: No
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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.
Heather Webber, PhD principal investigator
The University of Texas Health Science Center, Houston
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing TMS to dmPFC and TMS to dlPFC in people with Cocaine Use Disorder, run by The University of Texas Health Science Center, Houston 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 5 inclusion and 35 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: looking for participants now, as of the sponsor's last update on 8 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Heather Webber, PhD (713-486-2723, Heather.E.Webber@uth.tmc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in the amplitude of the Reward Positivity (RewP) component in microvolts in response to feedback on the Doors Task (time frame: Baseline(before iTBS session),immediately after iTBS session). 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 8 May 2025.