Opioid-use DisorderNCT05074524
Repetitive Transcranial Magnetic Stimulation to Reduce Heroin Cravings
A study testing Repetitive Transcranial Magnetic Stimulation in people with Opioid-use Disorder and Heroin Abuse, run by University of Nevada, Las Vegas at 1 site in United States.
Trial summary
The purpose of this research study is to test the effect of repetitive transcranial magnetic stimulation (rTMS) on opioid cravings among adult patients with Opioid Use Disorder. Read more about this study
- Who is it for?
- Ages 18 to 64 years
- Conditions the study is for
- Opioid-use Disorder, Heroin Abuse, Craving
- What is being tested?
- Repetitive Transcranial Magnetic Stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Oct 2021to 24 Jan 2022
- 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 64 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Adult aged 18-64, used heroin in the past 30 days;
- has a history of heroin use for at least one year;
- meets the clinical criteria for Opioid Use Disorder (only heroin use will be considered to meet this criteria);
- meets the clinician clearance using the rTMS Patient Screening Form.
Who cannot join
- do not currently take and medications for a substance use disorder such as methadone, buprenorphine, naltrexone, acamprosate, disulfiram;
- do not have a psychotic disorder;
- do not have a diagnosis of another substance use disorder;
- do not have a history of seizures or other neurological disorders including organic brain disease; epilepsy, stroke, brain lesions, multiple sclerosis, previous neurosurgery;
- do not have a personal history of head trauma that resulted in a loss of consciousness for more than 5 minutes and retrograde amnesia for more than 30 minutes;
- do not have a presence of non-fixed metal in body 30 cm to treatment coil.
- have not taken any medication for a substance use disorder within the last 72 hours before the first rTMS treatment;
- are not pregnant or think you may be pregnant.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Nevada, Las Vegas
Las Vegas, Nevada, 89154
About this study
Official title: Evaluating Repetitive Transcranial Magnetic Stimulation to Reduce Opioid Cravings in Adults Who Use Heroin
The purpose of this research study is to test the effect of repetitive transcranial magnetic stimulation (rTMS) on opioid cravings among adult patients with Opioid Use Disorder.
Read the detailed description
This study will use rTMS, a neuromagnetic and non-invasive treatment, to reduce opioid cravings in individuals who are diagnosed with opioid use disorder. Repetitive transcranial magnetic stimulation is currently used for the treatment of Major Depressive Disorder and Obsessive Compulsive Disorder in clinical practice. This proposed study will employ a randomized, single-blind, experimental design. Participants will be randomly assigned to two groups using a computer-based randomization program: treatment and sham-control groups.
- Being tested
- Repetitive Transcranial Magnetic Stimulation, Sham Repetitive Transcranial Magnetic Stimulation
- Medical subject headings
- Opioid-Related Disorders, Heroin Dependence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Repetitive Transcranial Magnetic StimulationDevice
Active rTMS treatment will be delivered at 10 Hz, 100% resting motor threshold, 2000 pulses delivered in five seconds per train with 10-second intra-train pause, delivered once daily five days per week, Monday through Friday for 10 days (10 total treatments). This protocol is adapted from Shen and colleagues (2016), who did not report any adverse events. Liu and colleagues (2020) also used the same protocol and only reported mild side effects of dizziness, headache, and insomnia, which resolved by the 30-day follow-up. However, it is unclear whether these side effects resolved sooner than the 30-day follow-up.
Sham Repetitive Transcranial Magnetic StimulationDevice
The control group will undergo the same seat positioning and comfort measures but will not have a resting motor threshold determination. The coil will be turned 90 degrees counter-clockwise, and the side of the coil will rest on the scalp over the area of the skull corresponding to the motor cortex, so the participant will feel the coil making contact. The same treatment protocol in the active rTMS group will be initiated to mimic the sound of rTMS treatment, though no pulses will be delivered to the participant because of the coil rotation.
| Study group | Role | What they receive |
|---|---|---|
| rTMS group | Experimental | Active rTMS treatment will be delivered at 10 Hz, 100% resting motor threshold, 2000 pulses delivered in five seconds per train with 10-second intra-train pause, delivered once daily five days per week, Monday through Friday for 10 days (10 total treatments). This protocol is adapted from Shen and colleagues (2016), who did not report any adverse events. Liu and colleagues (2020) also used the same protocol and only reported mild side effects of dizziness, headache, and insomnia, which resolved by the 30-day follow-up. However, it is unclear whether these side effects resolved sooner than the 30-day follow-up. Receives: Device: Repetitive Transcranial Magnetic Stimulation |
| Placebo Group | Sham comparator | The control group will undergo the same seat positioning and comfort measures but will not have a resting motor threshold determination. The coil will be turned 90 degrees counter-clockwise, and the side of the coil will rest on the scalp over the area of the skull corresponding to the motor cortex, so the participant will feel the coil making contact. The same treatment protocol in the active rTMS group will be initiated to mimic the sound of rTMS treatment, though no pulses will be delivered to the participant because of the coil rotation. Receives: Device: Sham Repetitive Transcranial Magnetic Stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Desires for Drug Questionnaire
This standardized questionnaire measures cravings for opioids. This scale includes a total of 13 items. Scoring is based on a 1-7 likert scale for each item. Specific items are assigned to one of three domains: desire, negative reinforcement, and control. A higher score indicates higher level of cravings. A lower score indicates a lesser level of opioid cravings, which is a better outcome. The primary outcome measure will be measured at various time points throughout the study to assess a change.
Measured: Days 1, 3, 5, 8, 10, 12, 42
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Oct 2021
- Study start6 Oct 2021
- Primary completion24 Jan 2022
- Study completion24 Jan 2022
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.
- 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
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Nevada, Las Vegas
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hyunhwa Lee, University of Nevada, Las Vegas
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05074524
- Sponsor's protocol ID
- 1748113-2
- Status last verified
- May 2022
- First submitted
- 30 Jul 2021
- Last updated
- 17 May 2022
- Results posted
- 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 17 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating Repetitive Transcranial Magnetic Stimulation to Reduce Opioid Cravings in Adults Who Use Heroin
- ClinicalTrials.gov ID
- NCT05074524
- Acronym / sponsor ID
- 1748113-2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- University of Nevada, Las VegasUniversity, hospital or other
- Study start
- 6 Oct 2021 (actual)
- Primary completion
- 24 Jan 2022 (actual)
- Study completion
- 24 Jan 2022 (actual)
- First posted
- 12 Oct 2021 (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 research study is to test the effect of repetitive transcranial magnetic stimulation (rTMS) on opioid cravings among adult patients with Opioid Use Disorder.
Detailed description
This study will use rTMS, a neuromagnetic and non-invasive treatment, to reduce opioid cravings in individuals who are diagnosed with opioid use disorder. Repetitive transcranial magnetic stimulation is currently used for the treatment of Major Depressive Disorder and Obsessive Compulsive Disorder in clinical practice. This proposed study will employ a randomized, single-blind, experimental design. Participants will be randomly assigned to two groups using a computer-based randomization program: treatment and sham-control groups.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| rTMS group | Experimental | Device: Repetitive Transcranial Magnetic StimulationActive rTMS treatment will be delivered at 10 Hz, 100% resting motor threshold, 2000 pulses delivered in five seconds per train with 10-second intra-train pause, delivered once daily five days per week, Monday through Friday for 10 days (10 total treatments). This protocol is adapted from Shen and colleagues (2016), who did not report any adverse events. Liu and colleagues (2020) also used the same protocol and only reported mild side effects of dizziness, headache, and insomnia, which resolved by the 30-day follow-up. However, it is unclear whether these side effects resolved sooner than the 30-day follow-up. |
| Placebo Group | Sham comparator | Device: Sham Repetitive Transcranial Magnetic StimulationThe control group will undergo the same seat positioning and comfort measures but will not have a resting motor threshold determination. The coil will be turned 90 degrees counter-clockwise, and the side of the coil will rest on the scalp over the area of the skull corresponding to the motor cortex, so the participant will feel the coil making contact. The same treatment protocol in the active rTMS group will be initiated to mimic the sound of rTMS treatment, though no pulses will be delivered to the participant because of the coil rotation. |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Adult aged 18-64, used heroin in the past 30 days;
- has a history of heroin use for at least one year;
- meets the clinical criteria for Opioid Use Disorder (only heroin use will be considered to meet this criteria);
- meets the clinician clearance using the rTMS Patient Screening Form.
Key exclusion criteria (8 listed)
- do not currently take and medications for a substance use disorder such as methadone, buprenorphine, naltrexone, acamprosate, disulfiram;
- do not have a psychotic disorder;
- do not have a diagnosis of another substance use disorder;
- do not have a history of seizures or other neurological disorders including organic brain disease; epilepsy, stroke, brain lesions, multiple sclerosis, previous neurosurgery;
- do not have a personal history of head trauma that resulted in a loss of consciousness for more than 5 minutes and retrograde amnesia for more than 30 minutes;
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 |
|---|---|---|
| Repetitive Transcranial Magnetic StimulationActive rTMS treatment will be delivered at 10 Hz, 100% resting motor threshold, 2000 pulses delivered in five seconds per train with 10-second intra-train pause, delivered once daily five days per week, Monday through Friday for 10 days (10 total treatments). This protocol is adapted from Shen and colleagues (2016), who did not report any adverse events. Liu and colleagues (2020) also used the same protocol and only reported mild side effects of dizziness, headache, and insomnia, which resolved by the 30-day follow-up. However, it is unclear whether these side effects resolved sooner than the 30-day follow-up. | Device | rTMS group |
| Sham Repetitive Transcranial Magnetic StimulationThe control group will undergo the same seat positioning and comfort measures but will not have a resting motor threshold determination. The coil will be turned 90 degrees counter-clockwise, and the side of the coil will rest on the scalp over the area of the skull corresponding to the motor cortex, so the participant will feel the coil making contact. The same treatment protocol in the active rTMS group will be initiated to mimic the sound of rTMS treatment, though no pulses will be delivered to the participant because of the coil rotation. | Device | Placebo Group |
Primary outcome
Desires for Drug Questionnaire
Time frame: Days 1, 3, 5, 8, 10, 12, 42
This standardized questionnaire measures cravings for opioids. This scale includes a total of 13 items. Scoring is based on a 1-7 likert scale for each item. Specific items are assigned to one of three domains: desire, negative reinforcement, and control. A higher score indicates higher level of cravings. A lower score indicates a lesser level of opioid cravings, which is a better outcome. The primary outcome measure will be measured at various time points throughout the study to assess a change.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 May 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Repetitive Transcranial Magnetic Stimulation in people with Opioid-use Disorder and Heroin Abuse, run by University of Nevada, Las Vegas 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 8 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 17 May 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. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Desires for Drug Questionnaire (time frame: Days 1, 3, 5, 8, 10, 12, 42). 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 17 May 2022.