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Repetitive Transcranial Magnetic Stimulation for Opiate Use Disorder (ArTMS)

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ClinicalTrials.gov Identifier: NCT03538444
Recruitment Status : Recruiting
First Posted : May 29, 2018
Last Update Posted : October 21, 2019
Sponsor:
Information provided by (Responsible Party):
Medical University of South Carolina

Brief Summary:
This double-blind, randomized, controlled trials will investigate the effect of accelerated, repeated transcranial magnetic stimulation on opiate craving and perceived pain .

Condition or disease Intervention/treatment Phase
Opiate Dependence Chronic Pain Device: Repetitive Transcranial Magnetic Stimulation Device: Sham rTMS Not Applicable

Detailed Description:

Prescription opiate use disorder (OUD) is common in the United States, with high morbidity and mortality. Despite the availability of opiate replacement therapies, many individuals continue to abuse opiates and relapse rates remain high. Uncontrolled pain and opiate craving are both commonly reported by OUD individuals attempting abstinence, and likely contribute to relapse. As such, development of novel treatment strategies targeting pain and craving would have important clinical implications.

Repetitive transcranial magnetic stimulation (rTMS) is a non-invasive brain stimulation technique which is currently FDA-approved as a treatment for major depressive disorder. TMS is actively being pursued as a treatment for chronic pain disorders as well as for substance use disorders. In chronic pain patients, there is promising data suggesting that treatment with excitatory rTMS to the dorsolateral pre-frontal cortex (DLPFC) can have an anti-pain effect. A single session of excitatory DLPFC rTMS can decrease the perception of laboratory induced pain, decrease the amount of self administered morphine following open gastric bypass surgery and decrease the affective and sensory components of pain following laparoscopic gastric-bypass surgery. While the effects of a single session last for only approximately 1 hour, repeated sessions appear to have an additive and more durable effect, and following 15 sessions, the subjective experience of provoked pain has been shown to decrease by as much as 37%. In addition to the literature in laboratory induced pain, there is also preliminary data suggesting that rTMS may be an effective treatment for chronic pain disorders. In substance use disordered populations, the use of rTMS has garnered significant attention as an innovative tool to decrease craving [see reviews:. Several single session rTMS studies have demonstrated that applying excitatory rTMS to the DLPFC can decrease cue-induced craving in nicotine, cocaine, and alcohol use disordered populations. As expected, single session studies have only found small temporary reductions in craving; however, these promising data have led to preliminary clinical trials using multiple sessions of rTMS in alcohol, nicotine and cocaine use disorders. The largest such clinical trial (n=130 smokers) demonstrated that 13 sessions of DLPFC rTMS resulted in six month tobacco abstinence rates of 33% .

To date there has been limited work examining the effect of rTMS on craving or pain in individuals with OUD. Drawing from the published literature suggesting that excitatory rTMS applied to the DLPFC can reduce both pain and craving, our group completed a preliminary sham-controlled crossover study in prescription OUD patients with chronic pain. Our data suggest that a single session of excitatory DLPFC rTMS acutely decreased opiate cue induced craving and thermal pain sensitivity in this group. The promising results from our single session trial parallel the single session results found in nicotine and cocaine use disordered populations which subsequently translated into positive multiple session clinical trials. As such, it follows that a trial utilizing multiple sessions of rTMS in OUD patients may yield positive results.

40 participants (20/group) admitted to an inpatient community treatment facility for opiate detoxification will be given 18 sessions of either active or sham rTMS applied to the DLPFC, in an accelerated fashion over three days (6-sessions each day).

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: 40 individuals (20 per group) will be randomly assigned to either active or sham rTMS.
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description: Neither participants nor investigators will know whether the participant is assigned to the active or sham condition.
Primary Purpose: Treatment
Official Title: A Double-Blind, Randomized, Controlled Trial, Utilizing Accelerated Repetitive Transcranial Magnetic Stimulation (rTMS) as a Tool to Decrease Pain and Craving in Hospitalized Patients With Opiate Use Disorder
Actual Study Start Date : September 28, 2018
Estimated Primary Completion Date : June 1, 2020
Estimated Study Completion Date : June 1, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Active rTMS
Participants will receive 18 sessions of active repetitive Transcranial Magnetic Stimulation over a period of three days. TMS consists of 3000 pulses of 10Hz stimulation applied to the left DLPFC using the beam F3 method
Device: Repetitive Transcranial Magnetic Stimulation
Repetitive transcranial magnetic stimulation (rTMS) is a non-invasive brain stimulation technique which is currently FDA-approved as a treatment for major depressive disorder
Other Name: Active rTMS

Placebo Comparator: Sham rTMS
Participants will receive 18 sessions of sham rTMS over a period of three days.
Device: Sham rTMS
Participants will undergo procedures that mimic rTMS, but that are inactive.




Primary Outcome Measures :
  1. Opiate craving [ Time Frame: Baseline and three days: Pre-assessment (day 1-prior to the first delivered rTMS treatment) compared to post assessment (AM of day4 the morning following the final of three days of rTMS) ]
    Change in cue-induced craving ratings on a 10 point Likert Scale



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Participants must be able to provide informed consent and function at an intellectual level sufficient to allow accurate completion of all assessment instruments.
  2. Participants must meet DSM-5 criteria for moderate or severe OUD. While individuals may also meet criteria for use disorders of other substances (with the exception of alcohol or benzodiazepines), they must identify prescription opiates as their primary substance of abuse.
  3. Participants must be admitted to the inpatient unit for opiate detoxification.
  4. Participants must consent to random assignment.

Exclusion Criteria:

  1. Participants who are pregnant will be excluded.
  2. Participants with a history of/or current psychotic disorder will be excluded.
  3. Participants with a history of dementia or other cognitive impairment will be excluded.
  4. Participants with active suicidal ideation, or a suicide attempt within the past 90 days will be excluded.
  5. Participants with contraindications to receiving rTMS (including a history of seizures, or any implanted metal above the neck) will be excluded.
  6. Those with unstable general medical conditions will be excluded.
  7. Those who are currently using naltrexone, or tramadol, will be excluded.
  8. Those with alcohol or benzodiazepine use disorders will be excluded due to increased risk of seizure.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03538444


Contacts
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Contact: Gregory Sahlem, MD 843-792-2123 sahlem@musc.edu
Contact: Aimee McRae-Clark, PharmD 843-792-5216 mcraeal@musc.edu

Locations
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United States, South Carolina
Medical University of South Carolina Recruiting
Charleston, South Carolina, United States, 29425
Contact: Gregory Sahlem, MD         
Principal Investigator: Gregory Sahlem, MD         
Sponsors and Collaborators
Medical University of South Carolina

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Responsible Party: Medical University of South Carolina
ClinicalTrials.gov Identifier: NCT03538444    
Other Study ID Numbers: Pro00077611
First Posted: May 29, 2018    Key Record Dates
Last Update Posted: October 21, 2019
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Additional relevant MeSH terms:
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Chronic Pain
Opioid-Related Disorders
Pain
Neurologic Manifestations
Signs and Symptoms
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Opiate Alkaloids
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents