Methamphetamine Use DisorderNCT06320366
Testing an Accelerated TMS Protocol for Methamphetamine Use Disorder
A study testing Active TMS in people with Methamphetamine Use Disorder, run by University of Colorado, Denver at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 21 to 65 years
- Conditions the study is for
- Methamphetamine Use Disorder
- What is being tested?
- Active TMS
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Sep 2024to 31 May 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 21 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 21-65 years inclusive;
- Meets DSM-5 criteria for past-year moderate or severe methamphetamine use disorder;
- By Timeline Follow Back endorses at least 10 days of methamphetamine use out of the last month;
- Provides a urine drug screen positive for methamphetamine;
- Able to provide informed consent;
- No change in current psychiatric medication regimen, or medication free, for at least 4 weeks prior to study entry;
- Adequate English proficiency for study consent, and completion of the study instruments.
Who cannot join
- Lifetime non-substance-induced psychotic disorders, schizophrenia, schizoaffective disorder or bipolar disorder defined by DSM-5;
- Current diagnosis of DSM-5 drug use disorder other than stimulant, cannabis or nicotine use disorder;
- Non-substance-induced manic episode within the past 3 years or major depressive episode in the past year;
- 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;
- Presence of a clinically significant abnormality on baseline MRI;
- Inability to have an MRI;
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- 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);
- Active criminal justice involvement (i.e., any unresolved legal problems that could jeopardize continuation or completion of the study);
- History of head injury with loss of consciousness for more than 15 minutes;
- Diagnosis of dementia;
- Prescribed benzodiazepines or anticonvulsants;
- Currently enrolled in formal substance use disorder treatment;
- Metal implants or non-removable metal objects above the waist;
- Lifetime history of prior clinical treatment with TMS;
- Serious risk of suicide or homicide;
- Unable/unwilling to follow the study procedures;
- History of intractable migraine;
- Assessed to be at risk for alcohol or opioid withdrawal.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Colorado Anschutz Medical Campus
Aurora, Colorado, 80045
Joseph T Sakai, MD, 303-724-7402, joseph.sakai@cuanschutz.edu
Kristen M Raymond, BA, 303-724-3196, kristen.raymond@cuanschutz.edu
About this study
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.
Read the 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.
- Conditions
- Methamphetamine Use Disorder
- Being tested
- Sham TMS, Active TMS
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sham TMSDevice
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 TMSDevice
The TMS Cool-B65 A/P coil delivers magnetic stimulation to targeted cortical structure.
| Study group | Role | What they receive |
|---|---|---|
| Sham TMS | Placebo comparator | Participants have baseline assessments/evaluation, are admitted to the inpatient research unit, randomized via permuted block design to 5 days of sham TMS, and then have weekly study visits for the next 12 weeks. Receives: Device: Sham TMS |
| Active TMS | Experimental | Participants have baseline assessments/evaluation, are admitted to the inpatient research unit, randomized via permuted block design to 5 days of active TMS, and then have weekly study visits for the next 12 weeks. Receives: Device: Active TMS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tolerability
Proportion completing at least 20 TMS session - sham vs. active
Measured: 5 days
Study emergent adverse events
Incidence of study emergent adverse events - sham vs. active
Measured: 12 weeks
Secondary outcomes (7)
Weeks of continuous abstinence
Number of weeks of continuous methamphetamine abstinence - sham vs. active as measured weekly by urine drug screen.
Measured: 12 weeks
Days of methamphetamine use
Number of days of methamphetamine use - sham vs. active as measured weekly by timeline followback interview.
Measured: 12 weeks
Time to first methamphetamine use
Time from end of TMS treatment to first methamphetamine use by timeline follow back or urine drug screen
Measured: 12 weeks
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.
Measured: 12 weeks
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.
Measured: 12 weeks
MRI cue craving
Cue craving data will be collected pre- and post-TMS stimulation in week 1
Measured: Pre- and Post- TMS stimulation in week 1
MRI resting state
Resting state data will be collected pre- and post-TMS stimulation in week 1
Measured: Pre- and Post- TMS stimulation in week 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2024
- Study start3 Sep 2024
- Primary completion31 May 2028 (estimated)
- Study completion31 May 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Methamphetamine Use DisorderStudies of the same condition, open and under way.
- More trials run by University of Colorado, DenverThe sponsor's other registered studies.
- 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
- Model description
- Sham vs. real Transcranial Magnetic Stimulation (TMS)
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Denver
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06320366
- Sponsor's protocol ID
- 23-1044
- Other IDs
- K24DA058882
- Status last verified
- Sep 2025
- First submitted
- 13 Mar 2024
- Last updated
- 3 Oct 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: No plan to share IPD.
Study at a glance
From the registry record, last updated by the sponsor on 3 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Testing an Accelerated TMS Protocol for Methamphetamine Use Disorder
- ClinicalTrials.gov ID
- NCT06320366
- Acronym / sponsor ID
- 23-1044
- Conditions
- Methamphetamine Use Disorder
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- University of Colorado, DenverUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- 3 Sep 2024 (actual)
- Primary completion
- 31 May 2028 (estimated)
- Study completion
- 31 May 2028 (estimated)
- First posted
- 20 Mar 2024 (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 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Sham vs. real Transcranial Magnetic Stimulation (TMS)
| Arm | Type | Receives |
|---|---|---|
| Sham TMS | Placebo comparator | Device: Sham TMSParticipants have baseline assessments/evaluation, are admitted to the inpatient research unit, randomized via permuted block design to 5 days of sham TMS, and then have weekly study visits for the next 12 weeks. |
| Active TMS | Experimental | Device: Active TMSParticipants have baseline assessments/evaluation, are admitted to the inpatient research unit, randomized via permuted block design to 5 days of active TMS, and then have weekly study visits for the next 12 weeks. |
Who may qualify
- Ages
- 21 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Age 21-65 years inclusive;
- Meets DSM-5 criteria for past-year moderate or severe methamphetamine use disorder;
- By Timeline Follow Back endorses at least 10 days of methamphetamine use out of the last month;
- Provides a urine drug screen positive for methamphetamine;
- Able to provide informed consent;
Key exclusion criteria (18 listed)
- Lifetime non-substance-induced psychotic disorders, schizophrenia, schizoaffective disorder or bipolar disorder defined by DSM-5;
- Current diagnosis of DSM-5 drug use disorder other than stimulant, cannabis or nicotine use disorder;
- Non-substance-induced manic episode within the past 3 years or major depressive episode in the past year;
- 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;
- Presence of a clinically significant abnormality on baseline MRI;
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 |
|---|---|---|
| Sham TMSThe 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. | Device | Sham TMS |
| Active TMSThe TMS Cool-B65 A/P coil delivers magnetic stimulation to targeted cortical structure. | Device | Active TMS |
Primary outcome
Tolerability
Time frame: 5 days
Proportion completing at least 20 TMS session - sham vs. active
Study emergent adverse events
Time frame: 12 weeks
Incidence of study emergent adverse events - sham vs. active
7 secondary outcomes
Weeks of continuous abstinence
Time frame: 12 weeks
Days of methamphetamine use
Time frame: 12 weeks
Time to first methamphetamine use
Time frame: 12 weeks
Methamphetamine craving
Time frame: 12 weeks
Methamphetamine craving on visual analog scale
Time frame: 12 weeks
MRI cue craving
Time frame: Pre- and Post- TMS stimulation in week 1
MRI resting state
Time frame: Pre- and Post- TMS stimulation in week 1
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Oct 2025.
- Individual participant dataSharing planned: No. No plan to share IPD.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Active TMS in people with Methamphetamine Use Disorder, run by University of Colorado, Denver 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 7 inclusion and 18 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: looking for participants now, as of the sponsor's last update on 3 Oct 2025. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Joseph T Sakai, MD (303-724-7402, joseph.sakai@cuanschtz.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Tolerability (time frame: 5 days). The study lists 2 primary outcomes in all. 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 3 Oct 2025.