Testing an Accelerated TMS Protocol for Methamphetamine Use Disorder

Methamphetamine Use Disorder Clinical Trial

Official title:

Testing an Accelerated TMS Protocol for Methamphetamine Use Disorder

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06320366
• Other study ID #: 23-1044
• Secondary ID: K24DA058882
• Status: Not yet recruiting
• Phase: N/A
• Start date: May 1, 2024
• Est. completion date: May 31, 2028

Study information

• Verified date: March 2024
• Source: University of Colorado, Denver
• Contact: Joseph T Sakai, MD
• Phone: 303-724-7402
• Email: joseph.sakai[@]cuanschtz.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The investigators will evaluate the effects of an accelerated Transcranial Magnetic Stimulation (TMS) protocol of the left dorsolateral prefrontal cortex (DLPFC) for moderate to severe methamphetamine use disorder. This is a randomized parallel group design to assess feasibility and safety, evaluate efficacy (use, craving) and identify magnetic resonance imaging (resting state and cue craving) associated with group/outcomes.

Description:

In a randomized double-blind parallel-group sham-controlled design (n=20) administer a 5-day accelerated iTBS protocol (40 treatments) to the left dorsolateral prefrontal cortex during a short inpatient stay. Magnetic resonance imaging will be completed pre-post TMS and participants will be followed for 12 weeks.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 20
• Est. completion date: May 31, 2028
• Est. primary completion date: May 31, 2028
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years to 65 Years

Eligibility

Inclusion Criteria:

1. Age 21-65 years inclusive;

2. Meets DSM-5 criteria for past-year moderate or severe methamphetamine use disorder;

3. By Timeline Follow Back endorses at least 10 days of methamphetamine use out of the last month;

4. Provides a urine drug screen positive for methamphetamine;

5. Able to provide informed consent;

6. No change in current psychiatric medication regimen, or medication free, for at least 4 weeks prior to study entry;

7. Adequate English proficiency for study consent, and completion of the study instruments.

Exclusion Criteria:

1. Lifetime non-substance-induced psychotic disorders, schizophrenia, schizoaffective disorder or bipolar disorder defined by DSM-5;

2. Current diagnosis of DSM-5 drug use disorder other than stimulant, cannabis or nicotine use disorder;

3. Non-substance-induced manic episode within the past 3 years or major depressive episode in the past year;

4. Current clinically significant neurological disorder or medical illness, including history of seizures, cardiovascular disease/cardiac event, which in the opinion of the study physician would make study participation unsafe;

5. Presence of a clinically significant abnormality on baseline MRI;

6. Inability to have an MRI;

7. Currently breastfeeding, is currently pregnant or lack of use of effective contraception in women of childbearing age, as assessed by urine pregnancy test and self-report (participants will consent to continue effective contraceptives during the study);

8. Active criminal justice involvement (i.e., any unresolved legal problems that could jeopardize continuation or completion of the study);

9. History of head injury with loss of consciousness for more than 15 minutes;

10. Diagnosis of dementia;

11. Prescribed benzodiazepines or anticonvulsants;

12. Currently enrolled in formal substance use disorder treatment;

13. Metal implants or non-removable metal objects above the waist;

14. Lifetime history of prior clinical treatment with TMS;

15. Serious risk of suicide or homicide;

16. Unable/unwilling to follow the study procedures;

17. History of intractable migraine;

18. Assessed to be at risk for alcohol or opioid withdrawal.

Related Conditions & MeSH terms

• Methamphetamine Use Disorder

Intervention

Device:
• Sham TMS
The TMS Cool-B65 A/P coil on its placebo side delivers electrical stimulation to the scalp (e.g., mimicking sensations associated with real stimulation) but does not provide magnetic stimulation to the targeted cortical structure.
• Active TMS
The TMS Cool-B65 A/P coil delivers magnetic stimulation to targeted cortical structure.

Locations

Country	Name	City	State
United States	University of Colorado Anschutz Medical Campus	Aurora	Colorado

Sponsors (2)

Lead Sponsor	Collaborator
University of Colorado, Denver	National Institute on Drug Abuse (NIDA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Tolerability	Proportion completing at least 20 TMS session - sham vs. active	5 days
Primary	Study emergent adverse events	Incidence of study emergent adverse events - sham vs. active	12 weeks
Secondary	Weeks of continuous abstinence	Number of weeks of continuous methamphetamine abstinence - sham vs. active as measured weekly by urine drug screen.	12 weeks
Secondary	Days of methamphetamine use	Number of days of methamphetamine use - sham vs. active as measured weekly by timeline followback interview.	12 weeks
Secondary	Methamphetamine craving	Craving as measured on the Stimulant Craving Questionnaire-Brief - sham vs. active. Each item is scored 0-6 (from Strongly Disagree=0 to Strongly Agree=6) with items #4 and #7 reverse scored. The investigators will average all 10 items as the total score, with higher scores indicating greater levels of craving.	12 weeks
Secondary	Methamphetamine craving on visual analog scale	Craving as measured on visual analog scale - sham vs. active. Scored 0 to 100 with 0=no craving and 100=the most craving.	12 weeks
Secondary	MRI cue craving	Cue craving data will be collected pre- and post-TMS stimulation in week 1	Pre- and Post- TMS stimulation in week 1
Secondary	MRI resting state	Resting state data will be collected pre- and post-TMS stimulation in week 1	Pre- and Post- TMS stimulation in week 1