tDCS to Decrease Opioid Relapse (UH3)

Opioid Use Disorder Clinical Trial

Official title:

tDCS to Decrease Opioid Relapse (UH3)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06432465
• Other study ID #: 1317333
• Secondary ID: 4UH3DA047793
• Status: Recruiting
• Phase: N/A
• Start date: April 17, 2024
• Est. completion date: December 31, 2026

Study information

• Verified date: May 2024
• Source: Butler Hospital
• Contact: Ana M Abrantes, Ph.D.
• Phone: 4014556440
• Email: ana_abrantes[@]brown.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Investigators will measure behavioral and brain responses following transcranial direct current stimulation (tDCS) to the dorsolateral prefrontal cortex (DLPFC) (anode on right DLPFC, cathode on the left DLPFC) delivered during cognitive control network (CCN) priming. In Phase I, the EEG provided validation of expected changes in these networks following tDCS stimulation of the DLPFC. In this current phase (II), the investigators will perform a larger randomized clinical trial (RCT) (active vs. sham control) to address long-term neurobehavioral outcomes, including opioid relapse, craving, and sustained EEG changes.

Description:

Investigators will perform an RCT in 100 opioid dependent participants who recently initiated buprenorphine or methadone. Participants will be randomized to receive five sessions of tDCS+CCN priming stimulation vs. sham tDCS+CCN priming. Participants will be assessed three times using electroencephalographic (EEG), once prior to tDCS+CCN priming, right after the completion of 5 sessions of tDCS+CCN priming (one week later), and again 10 weeks later.

This phase will address long-term (3- and 6-month) neurobehavioral outcomes, including opioid relapse, craving, and sustained EEG changes during a paradigm that challenges networks associated with craving (CR) and cognitive control (CCN). During the 24 weeks of buprenorphine or methadone maintenance treatment, the investigators will examine our primary clinical outcome, relapse (opioid use on >4 days per month and having an opioid positive urine screen), as well as days of opioid use.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: December 31, 2026
• Est. primary completion date: December 31, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years to 60 Years

Eligibility

Inclusion Criteria:

(a) current opioid dependence, (b) between 21-60 years of age, (c) recent initiation of buprenorphine or methadone (=30days), and (d) enrolled in Butler Hospital's Alcohol and Drug Inpatient Unit, Alcohol and Drug Partial Hospital Treatment Program, Intensive Outpatient Services, or Outpatient Services at Butler Hospital OR receive opioid-treatment services in the community.

Exclusion Criteria:

(a) current diagnosis of organic brain disorder (e.g., Parkinson's disease, Huntington's disease, multiple sclerosis, intracranial mass/infection, hydrocephalus), (b) bipolar, schizophrenia, schizoaffective, or schizophreniform disorder, or current psychosis associated with any disorder, (c) current suicidality, (d) evidence of significant neurocognitive dysfunction, (e) conditions associated with heightened tDCS risks, e.g., seizure disorder, nonremovable intracranial metal objects (other than dental fillings and dental implants), skin disease or active lesions on the scalp, migraine/other headache disorder with significant active symptoms, traumatic brain injury or skull fracture within the past year, any implanted medical devices or device components that can interact with electromagnetic fields or are controlled by physiological signals, (f) probation/parole requirements or an upcoming move that might interfere with protocol participation, (g) planning to terminate buprenorphine or methadone in less than 3 months, (h) current pregnancy or plan to become pregnant in the next month.

Related Conditions & MeSH terms

• Opioid Use Disorder
• Opioid-Related Disorders

Intervention

Device:
• tDCS
The anode will be placed over the right DLPFC (F4 on the EEG 10-20 system) and the cathode over the left DLPFC65 (F3) using 25cm2 sponges at an intensity of 2mA. Stimulation will be delivered via two saline-soaked surface sponge electrodes and a battery-driven, constant current stimulator (NeuroConn DC Stimulator Plus). This device includes a study mode, in which subject-specific codes are entered to deliver active or sham stimulation, keeping the administrator blinded. Sham stimulation will use a method in which stimulation will be ramped up and back down over a 30-second period at the beginning and end of sham tDCS.

Locations

Country	Name	City	State
United States	Butler Hospital	Providence	Rhode Island

Sponsors (2)

Lead Sponsor	Collaborator
Butler Hospital	National Institute on Drug Abuse (NIDA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in opioid craving	Penn Alcohol Craving (Modified for Opioids) (scoring: 0 - 30, higher scores = more craving); Penn Alcohol Craving (Modified for Opioids) (scoring: 0 - 30, higher scores = more craving); Penn Alcohol Craving (Modified for Opioids) (scoring: 0-30, higher scores = more craving)	2 weeks
Primary	change in EEG oscillatory targets	frontal theta activity during working memory	2 weeks
Primary	lower rates of opioid relapse	Timeline followback interview and urine toxicology	24 weeks