Methamphetamine Use DisorderPhase 1/2NCT05558358
Deep Brain Stimulation (DBS) for Methamphetamine Use Disorder
A Phase 1/2 study of Methamphetamine Use Disorder, run by University of Colorado, Denver at 1 site in United States.
Trial summary
We will evaluate the effects of deep brain stimulation (DBS) of bilateral nucleus accumbens (NAc) added to background treatment for treatment refractory Methamphetamine Use Disorder (MUD). Read more about this study
- Who is it for?
- Ages 22 to 65 years
- Conditions the study is for
- Methamphetamine Use Disorder
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 2 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Jan 2024to 31 May 2026
- Phase
- Phase 1/2
- 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 22 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults (men and non-pregnant or nursing women) between 22-65 years of age will be eligible for enrollment, if meeting the following criteria:
- Current diagnosis of DSM-5 MUD (with past year specifier of severe and at least a 5-year history);
- Failed at least 2 prior treatment episodes (defined as outpatient or inpatient, utilizing a previously validated psychosocial treatment for addiction such as cognitive behavioral therapy, contingency management, motivational interviewing (Stuart et al., 2019) and not counting episodes with only detoxification) for MUD, with at least 1 episode having been residential;
- Provides a urine drug screen positive for mAMP;
- Endorses at least 10 days of mAMP use in the past month;
- Able to complete 1 week of inpatient detoxification prior to surgery and 4 weeks of inpatient treatment following surgery;
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- No change in current psychiatric medication regimen, or medication free, for at least 4 weeks prior to entry;
- Able to provide informed consent;
- Able to comply with all testing and follow-up requirements as defined by study protocol (including providing a home address and two local collateral contacts);
- Medically able to undergo DBS procedure as assessed by Study Neurosurgeon;
- Has platelet count, PT and PTT within normal laboratory limits;
- Adequate English proficiency for study consent, and completion of the study instruments;
- Reside in the state of Colorado.
Who cannot join
- Lifetime non-substance-induced psychotic disorders, schizophrenia, or schizoaffective disorder defined by DSM-5;
- Current diagnosis of DSM-5 drug use disorder other than stimulant, alcohol, 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;
- Presence of a clinically significant abnormality on preoperative MRI;
- Inability to have an MRI;
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- Inability to undergo general anesthesia required for tunneling of extension cable and placement of the batteries;
- Pregnancy 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);
- Coagulopathy, as determined by PT, PTT, platelet count, and medical history;
- History of recurrent infections;
- Inability to adhere to the requirements of the study;
- Imminent risk of suicide as determined by Study Psychiatrist's assessment and investigators' clinical judgment or past-year suicide attempt, any positive response on baseline Columbia Suicide Severity Scale or history of parental completed suicide;
- 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, neurological illness (including primary seizure disorder);
- Diagnosis of dementia;
- Conditions requiring diathermy.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Colorado Anschutz Medical Campus
Aurora, Colorado, 80045
About this study
We will evaluate the effects of deep brain stimulation (DBS) of bilateral nucleus accumbens (NAc) added to background treatment for treatment refractory Methamphetamine Use Disorder (MUD). This is a small randomized cross-over study to demonstrate feasibility and safety, test treatment outcomes (use, craving), and identify novel biological targets (NAc local field potentials (LFP) and functional MRI).
Read the detailed description
In a randomized cross-over design of DBS of the nucleus accumbens (NAc) for treatment refractory methamphetamine use disorder (MUD, n=5), we will test safety, feasibility, effect on clinical outcomes (craving and use), and seek to identify biological targets (using cue craving during recording of local field potentials and MRI).
- Conditions
- Methamphetamine Use Disorder
- Being tested
- Experimental 1 - DBS of bilateral NAc - 6 months of active stimulation -- > 6 months of sham stimulation, Experimental 2 - DBS of bilateral NAc - 6 months of sham stimulation -- > 6 months of active stimulation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Experimental 1 - DBS of bilateral NAc - 6 months of active stimulation -- > 6 months of sham stimulationDevice
6 months of active stimulation -- > 6 months of sham stimulation
Experimental 2 - DBS of bilateral NAc - 6 months of sham stimulation -- > 6 months of active stimulationDevice
6 months of sham stimulation -- > 6 months of active stimulation
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Randomized sham-controlled crossover design - participants have baseline assessments/evaluation, 1 week detoxification, surgery, 30 days residential care, then begin DBS stimulation, 12 weeks IOP/CM and are followed for 52 weeks. Receives: Device: Experimental 1 - DBS of bilateral NAc - 6 months of active stimulation -- > 6 months of sham stimulation |
| 2 | Experimental | Randomized sham-controlled crossover design - participants have baseline assessments/evaluation, 1 week detoxification, surgery, 30 days residential care, then begin DBS stimulation, 12 weeks IOP/CM and are followed for 52 weeks. Receives: Device: Experimental 2 - DBS of bilateral NAc - 6 months of sham stimulation -- > 6 months of active stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of study-emergent adverse events
Participants will be closely monitored for adverse events throughout the study including regular meetings with study staff and administration of the COMBINE SAFTEE during each programming session.
Measured: 56 weeks
Secondary outcomes (12)
Methamphetamine use
Operationalized as the highest number of consecutive days of no methamphetamine use in the final month of sham vs. final month of active stimulation.
Measured: Measured during weeks 26-30 and weeks 52-56 (last month on stimulation and sham)
Methamphetamine use
Operationalized as the number of days methamphetamine is used in the final month of sham vs. final month of active stimulation.
Measured: Measured during weeks 26-30 and weeks 52-56 (last month on stimulation and sham)
Methamphetamine craving
Measured weekly using the Stimulant Craving Questionnaire-Brief where each item is scored 0-6 (from Strongly Disagree=0 to Strongly Agree=6) with items #4 and #7 reverse scored. We will average all 10 items as the total score, with higher scores indicating greater levels of craving in the final month of sham vs. final month of active stimulation.
Measured: Comparing weeks 26-30 and weeks 52-56
Local Field Potential
Electrophysiologic data - three types of LFP data that will be collected: (a.1) BrainSense™ Streaming assessed in the laboratory during the cue-craving task at baseline, 6, and 12 months; (a.2) BrainSense™ Events will be triggered by the participant using the patient programmer when he/she experiences craving; (a.3) BrainSense™Timeline records 10 minute averages of power spectral data within a 5 Hz window throughout the 12 month UG3 trial.
Measured: baseline through week 56
MRI
Cue craving MRI data will be collected at baseline, week 30 and week 56
Measured: 56 weeks
MRI
Resting state MRI data will be collected at baseline, week 30 and week 56
Measured: 56 weeks
Behavioral Inhibition System/Behavioral Approach System (BIS/BAS)
BIS/BAS will be collected at baseline, week 30 and week 56 Behavioral inhibition system score, assessing tendency to withdraw from aversive conditioned stimuli, and a behavioral activation score assessing tendency to approach appetitive stimuli.
This is a 24-item scale with all items rated on a 4 point scale. With appropriate reverse scoring, this will be used to create BIS score (items 2, 8, 13, 16, 19, 22, 24), BAS Drive (items 3, 9, 12, 21), BAS Fun Seeking (5, 10, 15, 20) and BAS Reward Responsiveness (items 4, 7, 14, 18, 23) scores.
Measured: 56 weeks
Impulsiveness
Barratt Impulsiveness Scale (BIS-11) will be collected at baseline, week 30 and week 56 This 30 item measure questionnaire (using a 1-4 scale for each item) generates a total score, along with Attentional, Motor and Nonplanning second order factors.
Measured: 56 weeks
Sensation seeking
This 40-item questionnaire, measured at baseline, week 30 and week 56, provides, with appropriate reverse scoring, a total score (items 1-40), and 4 subscales: Disinhibition (1, 12, 13, 25, 29, 30, 32, 35, 36), Boredom Susceptibility (2, 5, 7, 8, 15, 24, 27, 31, 34, 39), Thrill and Adventure Seeking (3, 11, 16, 17, 20, 21, 23, 28, 38, 40) and Experience Seeking (4, 6, 9, 10, 14, 18, 19, 22, 26, 37).
Measured: 56 weeks
Anhedonia
The Snaith-Hamilton Pleasure Scale, measured at baseline, week 30 and week 56, is a 14 item questionnaire (all rated on a 4 point Likert scale) and covers four domains of hedonic experience (interest/pastimes, social interaction, sensory experience and food/drink). With appropriate reverse scoring, we will use total score.
Measured: 56 weeks
Delay Discounting
The MCQ, measured at baseline, week 30 and week 56, is a 27 item self administered questionnaire that examines delay discounting and can be hand scored using available tables. We will use the mean of the k at indifference between 2 questions that reflect a change between choosing a delayed vs. immediate reward.
Measured: 56 weeks
Risk taking
Balloon Analog Risk Task (measured at baseline, week 30 and week 56) We will utilize the average number of pumps on un-popped balloons and mean balloons popped.
Measured: 56 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2022
- Study start15 Jan 2024
- Primary completion31 May 2026 (estimated)
- Study completion31 May 2026 (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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- All participants undergo surgery. Some receive 6 months of active DBS stimulation of the bilateral nucleus accumbens followed by 6 months of sham stimulation. While some receive the opposite order.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Denver
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA), University of Nebraska
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05558358
- Sponsor's protocol ID
- 18-0254
- Other IDs
- UG3DA054746
- Status last verified
- Apr 2025
- First submitted
- 19 Sep 2022
- Last updated
- 30 Apr 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Deep Brain Stimulation (DBS) for Methamphetamine Use Disorder
- ClinicalTrials.gov ID
- NCT05558358
- Acronym / sponsor ID
- 18-0254
- Conditions
- Methamphetamine Use Disorder
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 2 participants (actual)
- Lead sponsor
- University of Colorado, DenverUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA), University of Nebraska
- Study start
- 15 Jan 2024 (actual)
- Primary completion
- 31 May 2026 (estimated)
- Study completion
- 31 May 2026 (estimated)
- First posted
- 28 Sep 2022 (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.
We will evaluate the effects of deep brain stimulation (DBS) of bilateral nucleus accumbens (NAc) added to background treatment for treatment refractory Methamphetamine Use Disorder (MUD). This is a small randomized cross-over study to demonstrate feasibility and safety, test treatment outcomes (use, craving), and identify novel biological targets (NAc local field potentials (LFP) and functional MRI).
Detailed description
In a randomized cross-over design of DBS of the nucleus accumbens (NAc) for treatment refractory methamphetamine use disorder (MUD, n=5), we will test safety, feasibility, effect on clinical outcomes (craving and use), and seek to identify biological targets (using cue craving during recording of local field potentials and MRI).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- All participants undergo surgery. Some receive 6 months of active DBS stimulation of the bilateral nucleus accumbens followed by 6 months of sham stimulation. While some receive the opposite order.
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Device: Experimental 1 - DBS of bilateral NAc - 6 months of active stimulation -- > 6 months of sham stimulationRandomized sham-controlled crossover design - participants have baseline assessments/evaluation, 1 week detoxification, surgery, 30 days residential care, then begin DBS stimulation, 12 weeks IOP/CM and are followed for 52 weeks. |
| 2 | Experimental | Device: Experimental 2 - DBS of bilateral NAc - 6 months of sham stimulation -- > 6 months of active stimulationRandomized sham-controlled crossover design - participants have baseline assessments/evaluation, 1 week detoxification, surgery, 30 days residential care, then begin DBS stimulation, 12 weeks IOP/CM and are followed for 52 weeks. |
Who may qualify
- Ages
- 22 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Adults (men and non-pregnant or nursing women) between 22-65 years of age will be eligible for enrollment, if meeting the following criteria:
- Current diagnosis of DSM-5 MUD (with past year specifier of severe and at least a 5-year history);
- Failed at least 2 prior treatment episodes (defined as outpatient or inpatient, utilizing a previously validated psychosocial treatment for addiction such as cognitive behavioral therapy, contingency management, motivational interviewing (Stuart et al., 2019) and not counting episodes with only detoxification) for MUD, with at least 1 episode having been residential;
- Provides a urine drug screen positive for mAMP;
- Endorses at least 10 days of mAMP use in the past month;
Key exclusion criteria (16 listed)
- Lifetime non-substance-induced psychotic disorders, schizophrenia, or schizoaffective disorder defined by DSM-5;
- Current diagnosis of DSM-5 drug use disorder other than stimulant, alcohol, 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;
- Presence of a clinically significant abnormality on preoperative 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 |
|---|---|---|
| Experimental 1 - DBS of bilateral NAc - 6 months of active stimulation -- > 6 months of sham stimulation6 months of active stimulation -- > 6 months of sham stimulation | Device | 1 |
| Experimental 2 - DBS of bilateral NAc - 6 months of sham stimulation -- > 6 months of active stimulation6 months of sham stimulation -- > 6 months of active stimulation | Device | 2 |
Primary outcome
Incidence of study-emergent adverse events
Time frame: 56 weeks
Participants will be closely monitored for adverse events throughout the study including regular meetings with study staff and administration of the COMBINE SAFTEE during each programming session.
12 secondary outcomes
Methamphetamine use
Time frame: Measured during weeks 26-30 and weeks 52-56 (last month on stimulation and sham)
Methamphetamine use
Time frame: Measured during weeks 26-30 and weeks 52-56 (last month on stimulation and sham)
Methamphetamine craving
Time frame: Comparing weeks 26-30 and weeks 52-56
Local Field Potential
Time frame: baseline through week 56
MRI
Time frame: 56 weeks
MRI
Time frame: 56 weeks
Behavioral Inhibition System/Behavioral Approach System (BIS/BAS)
Time frame: 56 weeks
Impulsiveness
Time frame: 56 weeks
Sensation seeking
Time frame: 56 weeks
Anhedonia
Time frame: 56 weeks
Delay Discounting
Time frame: 56 weeks
Risk taking
Time frame: 56 weeks
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 30 Apr 2025.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study of 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 13 inclusion and 16 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: under way, not looking for participants, as of the sponsor's last update on 30 Apr 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of study-emergent adverse events (time frame: 56 weeks). 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 30 Apr 2025.