Back to resultsRepetitive Transcranial Magnetic Stimulation to Reduce Heroin Cravings
Primary Purpose
Opioid-use Disorder, Heroin Abuse, Craving
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Repetitive Transcranial Magnetic Stimulation
Sham Repetitive Transcranial Magnetic Stimulation
Sponsored by
About this trial
This is an interventional treatment trial for Opioid-use Disorder
Eligibility Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Sites / Locations
- University of Nevada, Las Vegas
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Sham Comparator
Arm Label
rTMS group
Placebo Group
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT05074524
First Posted
July 30, 2021
Last Updated
May 16, 2022
Sponsor
University of Nevada, Las Vegas
1. Study Identification
Unique Protocol Identification Number
NCT05074524
Brief Title
Repetitive Transcranial Magnetic Stimulation to Reduce Heroin Cravings
Official Title
Evaluating Repetitive Transcranial Magnetic Stimulation to Reduce Opioid Cravings in Adults Who Use Heroin
Study Type
Interventional
2. Study Status
Record Verification Date
May 2022
Overall Recruitment Status
Completed
Study Start Date
October 6, 2021 (Actual)
Primary Completion Date
January 24, 2022 (Actual)
Study Completion Date
January 24, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Nevada, Las Vegas
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
Yes
5. Study Description
Brief 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Opioid-use Disorder, Heroin Abuse, Craving, Transcranial Magnetic Stimulation
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
24 (Actual)
8. Arms, Groups, and Interventions
Arm Title
rTMS group
Arm Type
Experimental
Arm Description
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.
Arm Title
Placebo Group
Arm Type
Sham Comparator
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Repetitive Transcranial Magnetic Stimulation
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
Sham Repetitive Transcranial Magnetic Stimulation
Intervention Description
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.
Primary Outcome Measure Information:
Title
Desires for Drug Questionnaire
Description
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.
Time Frame
Days 1, 3, 5, 8, 10, 12, 42
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
64 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
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.
Facility Information:
Facility Name
University of Nevada, Las Vegas
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89154
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Repetitive Transcranial Magnetic Stimulation to Reduce Heroin Cravings
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