Opioid Use Disorder Clinical Trial
Official title:
Using Neuromodulation to Investigate Treatment Pathways Associated With Stress and Substance Use in Opioid Use Disorder
Opioid agonist treatments are the gold standard for treating opioid use disorder (OUD). Yet, even effective treatments average only 50% six-month retention. Despite extensive research into treatment options, it remains important to improve understanding of factors that contribute to relapse and identify interventions to mitigate these risks. Stress-exposure is problematic for people trying to recover from substance use disorders (SUDs) because it weakens inhibition of automatic behaviors and increases drug craving and likelihood of relapse. However, paths through which stress affects behavior are incompletely understood and current SUD treatments do not target effects of stress on drug use. This project will explore whether repetitive transcranial magnetic stimulation (rTMS) might improve treatment outcomes for people with OUD entering methadone treatment. The investigators will examine the impact of rTMS treatment over one of two theoretically-driven neural targets on substance use and cognitive outcomes associated with treatment success (executive function and emotional arousal).
The Competing Neurobehavioral Decisions Systems (CNDS) model of addiction suggests that people with SUDs have altered function and connectivity in fronto-cortical executive control regions (e.g. dorsolateral prefrontal cortex [dlPFC]) and fronto-cortical limbic control regions (e.g. medial prefrontal cortex [mPFC]). Namely, elevated activity in limbic circuitry results in hypersensitivity to drug cues and stress, and decreased executive control impairs the ability to resist drug urges. The CNDS theoretical framework can guide selection and testing of rTMS targets that could improve understanding of the mechanisms of SUDs and stress-induced drug use. Results from previous research suggest that therapeutic effects of rTMS for SUD could occur via excitation of dlPFC or inhibition of mPFC. The investigators will administer excitatory (10Hz) dlPFC rTMS and inhibitory (1Hz) mPFC rTMS (through an electromagnetic coil placed against the scalp) coupled with tasks of executive function and emotional arousal during stress and neutral conditions (guided imagery task using personalized scripts) in adults with OUD early in methadone treatment. The investigators will examine and compare how strengthening dlPFC activity or reducing mPFC activity may reverse stress-induced executive and emotional dysfunction, respectively, and improve treatment outcomes in persons with OUD seeking to abstain from opioid use. A mixed design study will be used to examine the effects of active rTMS vs. sham (within subject) over one of two locations: 10 Hz dlPFC rTMS (group 1) or 1 Hz mPFC rTMS (group 2) in subjects receiving methadone treatment for OUD. The general rTMS treatment protocol will be the same for both groups and will consist of 2 stimulation sessions per day, separated by ~30min, for 5 days (10 total stimulation sessions per treatment protocol). The sham protocol will be the same except the sham rTMS coil will be used. Participants will be randomly assigned to groups and complete the 2 conditions (active vs. sham rTMS) in random order. Immediately prior to and after each 5-day rTMS treatment protocol, participants will attend an assessment visit when they will complete multiple tasks during both stress (guided imagery stressor) and neutral conditions. These tasks are designed to measure executive function, emotional arousal, and drug-seeking behavior. ;
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT06021431 -
Virtual Reality Cognitive-Affective Training for Opioid Use Disorder- A Phase 2 RCT
|
N/A | |
Completed |
NCT06266572 -
Overcoming Stigma and Improving Outcomes for SUDs Through Education, Engagement, and Empowerment
|
Phase 1 | |
Recruiting |
NCT05037682 -
Pain and Opioid Management in Older Adults
|
N/A | |
Completed |
NCT06200740 -
Remotely Observed Methadone Evaluation
|
N/A | |
Not yet recruiting |
NCT06441604 -
Extended-release Buprenorphine as a Novel Low-dose Induction Strategy
|
Phase 2 | |
Recruiting |
NCT06028126 -
Superficial Parasternal Intercostal Plane Block in Cardiac Surgery Trial
|
N/A | |
Completed |
NCT02593474 -
Medication-Assisted Treatment for Youth With Substance Use Disorders
|
Phase 1 | |
Completed |
NCT02559973 -
Pharmacokinetics, Safety, and Tolerability of Depot Buprenorphine at Three Different Molecular Weights in Treatment-Seeking Subjects With Opioid Use Disorder
|
Phase 1 | |
Completed |
NCT02440256 -
Expanded HIV Care in Opioid Substitution Treatment (EHOST) Trial
|
N/A | |
Completed |
NCT05587998 -
A Study to Assess the Effect of AZD4041 on Respiratory Drive in Recreational Opioid Users.
|
Phase 1 | |
Terminated |
NCT04577144 -
An Observational Study of Environmental and Socioeconomic Factors in Opioid Recovery - Long Term
|
||
Recruiting |
NCT06001437 -
Following Outcomes Remotely Within Addiction Recovery Domains
|
||
Recruiting |
NCT05976646 -
Phase Ib/2a Drug-drug Interaction Study of a Combination of 45mg Dextromethorphan With 105 mg Bupropion
|
Phase 1/Phase 2 | |
Completed |
NCT05546229 -
Assessment of Methadone and Buprenorphine in Interstitial Fluid
|
||
Not yet recruiting |
NCT06104280 -
Medications for Opioid Use Disorder Photosensitive Retinal Ganglion Cell Function, Sleep, and Circadian Rhythms: Implications for Treatment
|
N/A | |
Not yet recruiting |
NCT06416020 -
Integrating MOUD in African American Community Settings (Better Together)
|
N/A | |
Recruiting |
NCT06206291 -
Cannabidiol for Opioid Addiction
|
Phase 2 | |
Completed |
NCT05552040 -
START NOW in the Treatment of Opioid Addicted Individuals
|
N/A | |
Recruiting |
NCT05459922 -
Adjunctive Bright Light Therapy for Opioid Use Disorder
|
N/A | |
Recruiting |
NCT05343169 -
Community-based Education, Navigation, and Support Intervention for Military Veterans
|
N/A |