Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05558358
Other study ID # 18-0254
Secondary ID UG3DA054746
Status Recruiting
Phase Phase 1/Phase 2
First received
Last updated
Start date January 15, 2024
Est. completion date February 1, 2025

Study information

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

Clinical 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). 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).


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).


Recruitment information / eligibility

Status Recruiting
Enrollment 5
Est. completion date February 1, 2025
Est. primary completion date February 1, 2025
Accepts healthy volunteers No
Gender All
Age group 22 Years to 65 Years
Eligibility Inclusion Criteria: Adults (men and non-pregnant or nursing women) between 22-65 years of age will be eligible for enrollment, if meeting the following criteria: 1. Current diagnosis of DSM-5 MUD (with past year specifier of severe and at least a 5-year history); 2. 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; 3. Provides a urine drug screen positive for mAMP; 4. Endorses at least 10 days of mAMP use in the past month; 5. Able to complete 1 week of inpatient detoxification prior to surgery and 4 weeks of inpatient treatment following surgery; 6. No change in current psychiatric medication regimen, or medication free, for at least 4 weeks prior to entry; 7. Able to provide informed consent; 8. 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); 9. Medically able to undergo DBS procedure as assessed by Study Neurosurgeon; 10. Has platelet count, PT and PTT within normal laboratory limits; 11. Adequate English proficiency for study consent, and completion of the study instruments; 12. Reside in the state of Colorado. Exclusion Criteria: 1. Lifetime non-substance-induced psychotic disorders, schizophrenia, or schizoaffective disorder defined by DSM-5; 2. Current diagnosis of DSM-5 drug use disorder other than stimulant, alcohol, 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; 5. Presence of a clinically significant abnormality on preoperative MRI; 6. Inability to have an MRI; 7. Inability to undergo general anesthesia required for tunneling of extension cable and placement of the batteries; 8. 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); 9. Coagulopathy, as determined by PT, PTT, platelet count, and medical history; 10. History of recurrent infections; 11. Inability to adhere to the requirements of the study; 12. 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; 13. Active criminal justice involvement (i.e., any unresolved legal problems that could jeopardize continuation or completion of the study); 14. History of head injury with loss of consciousness for more than 15 minutes, neurological illness (including primary seizure disorder); 15. Diagnosis of dementia; 16. Conditions requiring diathermy.

Study Design


Related Conditions & MeSH terms


Intervention

Device:
Experimental 1 - DBS of bilateral NAc - 6 months of active stimulation -- > 6 months of sham stimulation
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
6 months of sham stimulation -- > 6 months of active stimulation

Locations

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

Sponsors (3)

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

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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. 56 weeks
Secondary 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 during weeks 26-30 and weeks 52-56 (last month on stimulation and sham)
Secondary Methamphetamine use Operationalized as the number of days methamphetamine is used in the final month of sham vs. final month of active stimulation. Measured during weeks 26-30 and weeks 52-56 (last month on stimulation and sham)
Secondary 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. Comparing weeks 26-30 and weeks 52-56
Secondary 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. baseline through week 56
Secondary MRI Cue craving MRI data will be collected at baseline, week 30 and week 56 56 weeks
Secondary MRI Resting state MRI data will be collected at baseline, week 30 and week 56 56 weeks
Secondary 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.
56 weeks
Secondary 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. 56 weeks
Secondary 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). 56 weeks
Secondary 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. 56 weeks
Secondary 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. 56 weeks
Secondary 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. 56 weeks
See also
  Status Clinical Trial Phase
Completed NCT04178993 - Behavioral Effects of Drugs (Inpatient): 40 [Methamphetamine, Methylphenidate, Duloxetine] Phase 1
Completed NCT01982643 - Accelerated Development of Additive Pharmacotherapy Treatment for Methamphetamine Use Disorder Phase 1/Phase 2
Completed NCT03078075 - Accelerated Development of Additive Pharmacotherapy Treatment (ADAPT-2) for Methamphetamine Use Disorder Phase 3
Terminated NCT05711862 - The Effects of Suvorexant on Sleep, Stress, and Cue-reactivity in Methamphetamine Use Disorder Phase 2
Recruiting NCT05322954 - Study of the Safety and Feasibility of Psilocybin in Adults With Methamphetamine Use Disorder Phase 1
Recruiting NCT05760807 - Intranasal Oxytocin for Methamphetamine Withdrawal in Women N/A
Recruiting NCT04614584 - Mirtazapine and Methamphetamine Drug-drug Interaction Study Phase 1
Not yet recruiting NCT06320366 - Testing an Accelerated TMS Protocol for Methamphetamine Use Disorder N/A
Active, not recruiting NCT06279273 - A Study for the Risky Decision-making Deficits Among Methamphetamine Dependence Individuals and Treatment N/A
Active, not recruiting NCT04907357 - rTMS for Stimulant Use Disorders N/A
Completed NCT04713124 - A Telephone-delievered Intervention to Reduce Methamphetamine Use N/A
Active, not recruiting NCT04791969 - Intermittent Oral Naltrexone Enhanced With an Ecological Momentary Intervention for Methamphetamine-using MSM Phase 2
Completed NCT00572234 - Bupropion in the Treatment of Methamphetamine Dependence N/A
Terminated NCT03106571 - Study of Pomaglumetad and Methamphetamine Phase 1
Recruiting NCT06033365 - Beginning Early and Assertive Treatment for Methamphetamine Use Disorder N/A