Health TrialsbyHealthPanel

tDCS to Decrease Opioid Relapse (UH3)

ConditionOpioid Use Disorder
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age21-60
SponsorButler Hospital

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

current opioid dependence

between 21-60 years of age

recent initiation of buprenorphine or methadone (≤90 days)

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.

Disqualifiers

current diagnosis of organic brain disorder (e.g., Parkinson's disease, Huntington's disease, multiple sclerosis, intracranial mass/infection, hydrocephalus)

bipolar, schizophrenia, schizoaffective, or schizophreniform disorder, or current psychosis associated with any disorder

current suicidality

evidence of significant neurocognitive dysfunction

Trial design

Design model

Parallel

Treatments tested in this trial

  • active tDCS

    Device

    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 for 20 minutes via two saline-soaked surface sponge electrodes and a battery-driven, constant current stimulator (NeuroConn DC Stimulator Plus).

  • sham tDCS

    Device

    Same device and procedures as active tDCS with the exception that the 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.

Treatment groups

100 Participants
are divided into 2 treatment groups
Group A: active tDCSActive comparator 1 intervention
Group B: sham tDCSSham comparator 1 intervention

Trial outcomes

Primary outcomes

1

Opioid Craving

Modified Penn Alcohol Craving (0 = no craving to 30 = extreme craving)

Time frame
2 weeks

Secondary outcomes

1

EEG theta activity

theta event rate during working memory task

Time frame
2 weeks
2

opioid relapse

Timeline Follow back

Time frame
24 weeks

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Butler Hospital

Lead sponsor

National Institute on Drug Abuse (NIDA)

Collaborator

Source ClinicalTrials.gov
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