Methamphetamine Use Disorder
Conditions
Brief 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.
Detailed 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.
Interventions
DEVICESham 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.
DEVICEActive TMS
The TMS Cool-B65 A/P coil delivers magnetic stimulation to targeted cortical structure.
Sponsors
National Institute on Drug Abuse (NIDA)
University of Colorado, Denver
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Masking description
Participant and all study personnel are blinded.
Intervention model description
Sham vs. real Transcranial Magnetic Stimulation (TMS)
Eligibility
Sex/Gender
ALL
Age
21 Years to 65 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Study emergent adverse events | 12 weeks | Incidence of study emergent adverse events - sham vs. active |
| Tolerability | 5 days | Proportion completing at least 20 TMS session - sham vs. active |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time to first methamphetamine use | 12 weeks | Time from end of TMS treatment to first methamphetamine use by timeline follow back or urine drug screen |
| Methamphetamine craving | 12 weeks | 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. |
| Weeks of continuous abstinence | 12 weeks | Number of weeks of continuous methamphetamine abstinence - sham vs. active as measured weekly by urine drug screen. |
| MRI cue craving | Pre- and Post- TMS stimulation in week 1 | Cue craving data will be collected pre- and post-TMS stimulation in week 1 |
| MRI resting state | Pre- and Post- TMS stimulation in week 1 | Resting state data will be collected pre- and post-TMS stimulation in week 1 |
| Methamphetamine craving on visual analog scale | 12 weeks | Craving as measured on visual analog scale - sham vs. active. Scored 0 to 100 with 0=no craving and 100=the most craving. |
| Days of methamphetamine use | 12 weeks | Number of days of methamphetamine use - sham vs. active as measured weekly by timeline followback interview. |
Countries
United States
Contacts
Primary ContactJoseph T Sakai, MD
Backup ContactKristen M Raymond, BA
Outcome results
None listed