Opioid-use DisorderNCT03653169
Use of Transcranial Magnetic Stimulation to Reduce Craving for Individuals With Opioid Use Disorder Taking Buprenorphine
A study testing Transcranial Magnetic Stimulation in people with Opioid-use Disorder, run by Brigham and Women's Hospital at 1 site in United States.
Trial summary
The aim of this study is to investigate the effects of transcranial magnetic stimulation (TMS) on craving in individuals treated with buprenorphine for opioid use disorder. In this study, individuals will receive 10 sessions of TMS (twice daily for 5 days). Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Opioid-use Disorder
- What is being tested?
- Transcranial Magnetic Stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2021to Jun 2021
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged 18-65 years old
- Initiated treatment with buprenorphine for opioid use disorder within the last 3 months
- Be able to understand, read and write English.
- If female and of childbearing age, agree to use acceptable birth control during the study treatment period (oral contraceptives, history of tubal ligation, history of a hysterectomy, or a reliable barrier method) during the study treatment period.
Who cannot join
- Lifetime history of bipolar disorder or psychotic disorder,
- Current depression as rated by PHQ-9 ≥ 20 (Kroenke, Spitzer, and Williams 2001, Suzuki et al. 2015)
- Moderate chronic pain (pain intensity rated ≥ 40 on 100-point VAS lasting at least 6 months (Stein et al. 2015)
- History of alcohol use disorder as rated by AUDIT-C ≥ 4 (at risk) (Babor et al. 2001)
- History of complicated withdrawal from alcohol (i.e. delirium tremens, seizure)
- Substance use disorder in the past year (other than opioid or nicotine), as assessed by drug screens,
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- Neurologic disease including stroke, seizure, migraine, or severe head injury
- Major medical conditions that are not well-controlled or under the care of a physician
- Device (i.e. pacemaker, cochlear prosthesis, neurostimulator, intraocular metallic fragments) or ferromagnetic implant above the neck (within 30 cm of coil),
- Medication that lowers seizure threshold (i.e. immediate release bupropion, psychostimulants, tricyclic antidepressants) or impairs neuroplasticity (i.e. benzodiazepines)
- Pregnant
Trial locations and contacts
1 site in 1 country.
United States1 site
Brigham & Women's Hospital
Boston, Massachusetts, 02115
About this study
The aim of this study is to investigate the effects of transcranial magnetic stimulation (TMS) on craving in individuals treated with buprenorphine for opioid use disorder. In this study, individuals will receive 10 sessions of TMS (twice daily for 5 days). The investigators will assess craving, substance use, and mood throughout the study and 1-2 weeks post-treatment.
Read the detailed description
The aim of this study is to investigate the effects of transcranial magnetic stimulation (TMS) on craving in individuals treated with buprenorphine for opioid use disorder. Investigators will enroll subjects aged 18-65 years old who are currently in treatment with buprenorphine for opioid use disorder. Included subjects will have initiated treatment with buprenorphine in the last 3 months, be able to read, write, and understand English, and, if female, agree to use contraception. Subjects will be excluded if they have a history of bipolar or psychotic illness, current depression, use substances other than opioids, take medications that lower seizure threshold or impair neuroplasticity, have chronic pain, have a history of seizure or any other uncontrolled medical issue, or have a device or ferromagnetic implant in the head or neck. Enrolled subjects will receive 10 (twice daily for 5 days) sessions of active TMS (intermittent theta burst stimulation) to the left dorsolateral prefrontal cortex (L DLPFC) on consecutive weekdays. Investigators will assess craving, substance use, and mood throughout the study and 1-2 weeks post-treatment completion.
- Conditions
- Opioid-use Disorder
- Being tested
- Transcranial Magnetic Stimulation
- Keywords
- Transcranial Magnetic Stimulation
- Medical subject headings
- Opioid-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcranial Magnetic StimulationDevice
TMS is a form of noninvasive brain stimulation. An external electromagnetic coil is placed on the head, and a large current is passed through an insulated wire coil held flat on the surface of a subject's scalp in a fraction of a millisecond. This pulse of current induces a weak electrical current within the surface brain cortex. Repetitive trains of TMS pulses (repetitive TMS or rTMS) can transiently modulate corticospinal excitability following the rTMS train. When current is delivered at high frequency (10 Hz), it may simultaneously increase the activity of the brain at this site. In this study, individuals will receive 10 treatments with intermittent theta burst stimulation (twice daily for 5 days).
| Study group | Role | What they receive |
|---|---|---|
| Open-Label Active TMS | Experimental | All subjects will receive open-label treatment with active Transcranial Magnetic Stimulation (TMS) Receives: Device: Transcranial Magnetic Stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cue-Induced Craving, as measured by 0-100 Visual Analog Scale
Visual Analog Scale (0-100, where 0 = no craving, 100 = maximum craving)
Measured: End of TMS Treatments (1 week)
Drug Craving, as measured by 0-100 Visual Analog Scale
Visual Analog Scale (0-100, where 0 = no craving, 100 = maximum craving)
Measured: End of TMS Treatments (1 week)
Secondary outcomes (9)
Opioid Use and Relapse, as measured by Timeline Followback Calendar (days of opioid use)
Timeline Followback calendar, which measures days of opioid use over the past 2 weeks
Measured: End of TMS Treatments (1 week)
Retention in Buprenorphine Treatment
Treatment Retention: subjects actively engaged in buprenorphine treatment, attending appointments
Measured: End of TMS Treatments (1 week)
Symptoms of Depression, as measured by the Quick Inventory of Depressive Symptomatology-Self-Report (QIDS-SR-16)
Quick Inventory of Depressive Symptomatology-Self-Report (QIDS-SR-16), where higher score indicates more severe depressive symptoms
Measured: End of TMS Treatments (1 week)
Drug Craving, as measured by 0-100 Visual Analog Scale
Visual Analog Scale (0-100, where 0 = no craving, 100 = maximum craving)
Measured: 1-2 weeks after completion of TMS treatments
Opioid Use and Relapse, as measured by Timeline Followback Calendar (days of opioid use)
Timeline Followback calendar, which measures days of opioid use over the past month
Measured: 1-2 weeks after completion of TMS treatments
Retention in Buprenorphine Treatment
Treatment Retention: subjects actively engaged in buprenorphine treatment, attending appointments
Measured: 1-2 weeks after completion of TMS treatments
Symptoms of Depression, as measured by the Quick Inventory of Depressive Symptomatology-Self-Report (QIDS-SR-16)
Quick Inventory of Depressive Symptomatology-Self-Report (QIDS-SR-16), where higher score indicates more severe depressive symptoms
Measured: 1-2 weeks after completion of TMS treatments
Neuropsychologic Testing Battery
Penn Computerized Neuropsychologic Battery
Measured: End of TMS treatment (1 week)
Impulsivity
Barratt Impulsivity Scale
Measured: End of TMS treatment (1 week)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2018
- Study startJan 2021 (estimated)
- Primary completionJun 2021 (estimated)
- Study completionJun 2021 (estimated)
Why it stopped: Investigator left institution
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Opioid-use DisorderStudies of the same condition, open and under way.
- More trials run by Brigham and Women's HospitalThe 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Brigham and Women's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Heather Burrell Ward, Brigham and Women's Hospital
- Investigators
- Heather B Ward, MD, Principal investigator, Brigham and Women's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03653169
- Sponsor's protocol ID
- 100313439
- Status last verified
- Feb 2022
- First submitted
- 27 Aug 2018
- Last updated
- 14 Mar 2022
- 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 14 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of Transcranial Magnetic Stimulation to Reduce Craving for Individuals With Opioid Use Disorder Taking Buprenorphine
- ClinicalTrials.gov ID
- NCT03653169
- Acronym / sponsor ID
- 100313439
- Conditions
- Opioid-use Disorder
- Keywords
- Transcranial Magnetic Stimulation
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Investigator left institution
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Brigham and Women's HospitalUniversity, hospital or other
- Study start
- Jan 2021 (estimated)
- Primary completion
- Jun 2021 (estimated)
- Study completion
- Jun 2021 (estimated)
- First posted
- 31 Aug 2018 (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 aim of this study is to investigate the effects of transcranial magnetic stimulation (TMS) on craving in individuals treated with buprenorphine for opioid use disorder. In this study, individuals will receive 10 sessions of TMS (twice daily for 5 days). The investigators will assess craving, substance use, and mood throughout the study and 1-2 weeks post-treatment.
Detailed description
The aim of this study is to investigate the effects of transcranial magnetic stimulation (TMS) on craving in individuals treated with buprenorphine for opioid use disorder. Investigators will enroll subjects aged 18-65 years old who are currently in treatment with buprenorphine for opioid use disorder. Included subjects will have initiated treatment with buprenorphine in the last 3 months, be able to read, write, and understand English, and, if female, agree to use contraception. Subjects will be excluded if they have a history of bipolar or psychotic illness, current depression, use substances other than opioids, take medications that lower seizure threshold or impair neuroplasticity, have chronic pain, have a history of seizure or any other uncontrolled medical issue, or have a device or ferromagnetic implant in the head or neck. Enrolled subjects will receive 10 (twice daily for 5 days) sessions of active TMS (intermittent theta burst stimulation) to the left dorsolateral prefrontal cortex (L DLPFC) on consecutive weekdays. Investigators will assess craving, substance use, and mood throughout the study and 1-2 weeks post-treatment completion.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Open-Label Active TMS | Experimental | Device: Transcranial Magnetic StimulationAll subjects will receive open-label treatment with active Transcranial Magnetic Stimulation (TMS) |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Aged 18-65 years old
- Initiated treatment with buprenorphine for opioid use disorder within the last 3 months
- Be able to understand, read and write English.
- If female and of childbearing age, agree to use acceptable birth control during the study treatment period (oral contraceptives, history of tubal ligation, history of a hysterectomy, or a reliable barrier method) during the study treatment period.
Key exclusion criteria (11 listed)
- Lifetime history of bipolar disorder or psychotic disorder,
- Current depression as rated by PHQ-9 ≥ 20 (Kroenke, Spitzer, and Williams 2001, Suzuki et al. 2015)
- Moderate chronic pain (pain intensity rated ≥ 40 on 100-point VAS lasting at least 6 months (Stein et al. 2015)
- History of alcohol use disorder as rated by AUDIT-C ≥ 4 (at risk) (Babor et al. 2001)
- History of complicated withdrawal from alcohol (i.e. delirium tremens, seizure)
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 |
|---|---|---|
| Transcranial Magnetic StimulationTMS is a form of noninvasive brain stimulation. An external electromagnetic coil is placed on the head, and a large current is passed through an insulated wire coil held flat on the surface of a subject's scalp in a fraction of a millisecond. This pulse of current induces a weak electrical current within the surface brain cortex. Repetitive trains of TMS pulses (repetitive TMS or rTMS) can transiently modulate corticospinal excitability following the rTMS train. When current is delivered at high frequency (10 Hz), it may simultaneously increase the activity of the brain at this site. In this study, individuals will receive 10 treatments with intermittent theta burst stimulation (twice daily for 5 days). | Device | Open-Label Active TMS |
Primary outcome
Cue-Induced Craving, as measured by 0-100 Visual Analog Scale
Time frame: End of TMS Treatments (1 week)
Visual Analog Scale (0-100, where 0 = no craving, 100 = maximum craving)
Drug Craving, as measured by 0-100 Visual Analog Scale
Time frame: End of TMS Treatments (1 week)
Visual Analog Scale (0-100, where 0 = no craving, 100 = maximum craving)
9 secondary outcomes
Opioid Use and Relapse, as measured by Timeline Followback Calendar (days of opioid use)
Time frame: End of TMS Treatments (1 week)
Retention in Buprenorphine Treatment
Time frame: End of TMS Treatments (1 week)
Symptoms of Depression, as measured by the Quick Inventory of Depressive Symptomatology-Self-Report (QIDS-SR-16)
Time frame: End of TMS Treatments (1 week)
Drug Craving, as measured by 0-100 Visual Analog Scale
Time frame: 1-2 weeks after completion of TMS treatments
Opioid Use and Relapse, as measured by Timeline Followback Calendar (days of opioid use)
Time frame: 1-2 weeks after completion of TMS treatments
Retention in Buprenorphine Treatment
Time frame: 1-2 weeks after completion of TMS treatments
Symptoms of Depression, as measured by the Quick Inventory of Depressive Symptomatology-Self-Report (QIDS-SR-16)
Time frame: 1-2 weeks after completion of TMS treatments
Neuropsychologic Testing Battery
Time frame: End of TMS treatment (1 week)
Impulsivity
Time frame: End of TMS treatment (1 week)
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Mar 2022.
- 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. This study is not recruiting at the moment.
Heather B Ward, MD principal investigator
Brigham and Women's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transcranial Magnetic Stimulation in people with Opioid-use Disorder, run by Brigham and Women's Hospital 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 11 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: withdrawn, as of the sponsor's last update on 14 Mar 2022. 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?
The study was withdrawn before enrolling participants, so there are no results.
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?
Cue-Induced Craving, as measured by 0-100 Visual Analog Scale (time frame: End of TMS Treatments (1 week)). 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 14 Mar 2022.