University of Colorado, Denver
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).
Methamphetamine Use Disorder
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
Phase 1
Phase 2
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 Type : | Interventional |
Estimated Enrollment : | 5 participants |
Masking : | Double |
Masking Description : | Participants and all study personnel are blinded to subject assignment except the physician completing DBS programming. |
Primary Purpose : | Treatment |
Official Title : | Deep Brain Stimulation (DBS) for Methamphetamine Use Disorder |
Actual Study Start Date : | January 15, 2024 |
Estimated Primary Completion Date : | February 1, 2025 |
Estimated Study Completion Date : | February 1, 2025 |
Arm | Intervention/treatment |
---|---|
Experimental: 1 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. |
Device: Experimental 1 - DBS of bilateral NAc - 6 months of active stimulation -- > 6 months of sham stimulation |
Experimental: 2 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. |
Device: Experimental 2 - DBS of bilateral NAc - 6 months of sham stimulation -- > 6 months of active stimulation |
Ages Eligible for Study: | 22 Years to 65 Years |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.
Recruiting
University of Colorado Anschutz Medical Campus
Aurora, Colorado, United States, 80045