NCT03842137

tDCS to Decrease Opioid Relapse (UG3)

Completed NA Results posted Last updated 24 October 2024

What this trial tests

NA trial testing tDCS in Opioid Dependence in 62 participants. Completed in 31 August 2023.

Timeline

4 June 2019

Primary endpoint
30 April 2023

31 August 2023

Quick facts

Lead sponsor	Butler Hospital
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	treatment
Enrollment	62
Start date	4 June 2019
Primary completion	30 April 2023
Estimated completion	31 August 2023
Sites	1 location across United States

Drugs / interventions tested

• tDCS — full drug profile →
• sham tDCS

Conditions studied

• Opioid Dependence — all drugs for Opioid Dependence →
• Craving — all drugs for Craving →

Sponsor

Butler Hospital

Who can join

Adults 21 to 50, any sex, with Opioid Dependence or Craving. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Opioid Craving Primary · 2 week

Penn Alcohol Craving (Modified for Opioids). This is a 5-item measure, with each item scored 0 to 6. Items are summed for a total score from 0 to 30. Higher scores = more craving.

Group	Value	95% CI
tDCS	8.92	± 1.10
Sham tDCS	8.32	± 1.12

EEG Theta Brainwave Activity Secondary · 2 weeks

Theta event rate is examined as the number of times/second that brainwaves within the theta frequency range (4-7 Hz). Higher event rates reflect more activity during working memory task.

Group	Value	95% CI
tDCS	.38	± .06
Sham tDCS	.33	± .05

Adverse events — posted to ClinicalTrials.gov

Time frame: 2-weeks. Reporting threshold: 2%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

tDCS

Serious: 0/27 (0%)

Deaths: 0/27

Sham tDCS

Serious: 0/27 (0%)

Deaths: 0/27

Other adverse events (3 terms — click to expand)

Reaction	System	tDCS	Sham tDCS
Nausea	Gastrointestinal disorders	—	—
Headache	General disorders	—	—
Head Itchiness	Skin and subcutaneous tissue disorders	—	—

Data from ClinicalTrials.gov NCT03842137 adverse events section.

Sponsor's own description

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 electroencephalographic (EEG), once prior to tDCS+CCN priming and again at the completion of 5 sessions of tDCS+CCN priming (one week later). EEG will provide validation of expected changes in these networks following tDCS stimulation of the DLPFC.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.