tDCS to Decrease Opioid Relapse

Opioid Dependence Clinical Trial

Official title:

tDCS to Decrease Opioid Relapse

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03842137
• Other study ID #: 1810-001
• Secondary ID: UG3DA047793
• Status: Completed
• Phase: N/A
• Start date: June 4, 2019
• Est. completion date: August 31, 2023

Study information

• Verified date: October 2023
• Source: Butler Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

In the current proposal, the 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. Participants with opioid dependence, in the first month of prescribed buprenorphine or methadone, will be assessed twice using functional magnetic resonance imaging (FMRI) and electroencephalographic (EEG), once prior to tDCS+CCN priming and again at the completion of 5 sessions of tDCS+CCN priming (one week later). Task-based and resting state functional connectivity will be used to examine networks associated with craving (CR) and cognitive control. In Phase 1, FMRI and EEG will provide validation of expected changes in these networks following tDCS stimulation of the DLPFC. In phase 2, the investigators will perform a larger randomized clinical trial (RCT) (vs. sham control) to address long-term neurobehavioral outcomes, including opioid relapse, craving, and sustained FMRI changes.

Description:

This study has two phases. In phase one (UG3), the investigators propose to use FMRI to quantify changes in brain function and EEG to examine oscillatory brain changes as well as self-reported craving before and after administration of five sessions of tDCS+Cognitive Control Network (CCN) priming stimulation vs. sham tDCS+CCN priming (randomized control trial) in 60 opioid dependent participants who recently initiated buprenorphine or methadone. Participants in the first month of prescribed buprenorphine or methadone will be assessed using FMRI and EEG, once prior to tDCS and again one week later after completion of 5 sessions of tDCS+CCN priming. With a focus on the craving outcome, the investigators will use two task-based FMRI paradigms that challenge networks associated with craving (CR) and cognitive control (CCN), and will examine these and the salience network using resting state functional connectivity. In Phase 1, FMRI and EEG will be expected to provide 1) validation of expected network and oscillatory changes from tDCS-targeting and 2) an effect size for DLPFC vs sham stimulation. Go/no go criteria for the UG3 phase will be demonstration of greater FMRI change in any node of the CR or CCN networks or enhanced frontal theta power during a WM task AND greater change (at least 10% difference between conditions, controlling for baseline craving) in subjective craving measured during a cue reactivity task or outside the FMRI following the tDCS+CCN priming intervention compared to sham tDCS+CCN priming. In phase 2, the investigators will perform a larger RCT using the same treatment protocol 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. Phase two will address long-term (3-month) neurobehavioral outcomes, including opioid relapse, craving, and sustained fMRI changes during a paradigm that challenges networks associated with craving (CR) and cognitive control (CCN). During the 12 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: Completed
• Enrollment: 62
• Est. completion date: August 31, 2023
• Est. primary completion date: April 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years to 50 Years

Eligibility

Inclusion Criteria:

• current opioid dependence
• between 21-50 years of age
• recent initiation of buprenorphine or methadone (<30 days)

Exclusion Criteria:

• current criteria for a DSM-V diagnosis of bipolar disorder, schizophrenia, schizo-affective, schizophreniform, or paranoid disorder
• current suicidality
• evidence of neurocognitive dysfunction
• contraindications for tDCS (e.g seizure disorder)
• probation/parole requirements or an upcoming move that might interfere with protocol participation
• planning to terminate buprenorphine in less than 3 months
• scalp lesions near the tDCS electrode sites

Exclusion Criteria related to FMRI scanning are:

• history of neurological disorder (e.g., epilepsy, stroke, brain injury with loss of consciousness>10 min)
• impaired uncorrected vision
• MRI contraindications (e.g., claustrophobia, specific metallic implants and injuries, and pregnancy)

Related Conditions & MeSH terms

• Craving
• Opioid Dependence
• Opioid-Related Disorders

Intervention

Device:
• tDCS
Each participant will undergo 5 consecutive (i.e., business days) sessions of active tDCS delivered to the DLPFC. During each session, participants are engaging in tasks that activate the cognitive control network.
• sham tDCS
Each participant will undergo 5 consecutive (i.e., business days) sessions of sham tDCS delivered to the DLPFC. During each session, participants are engaging in tasks that activate the cognitive control network.

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	Visual Analog Craving scale (scoring: 1 - 10, with 1 = no craving and 10 = extreme craving; lower scores = less craving and higher scores = more craving)	2 week
Primary	change in the saliency network	activity in any node of the proposed network	2 week
Primary	change in the cognitive control network	activity in any node of the proposed network	2 week
Primary	change in EEG oscillatory targets	frontal theta power during working memory	2 week
Primary	lower rates of opioid relapse	Timeline follow-back interview	3 month