Butler Hospital
Providence, Rhode Island, 02906, United States
Location status: Recruiting
Location contact
Ana M Abrantes, Ph.D.
CONTACT
Ana M. Abrantes, Ph.D.
PRINCIPAL_INVESTIGATOR
Michael Stein, M.D.
PRINCIPAL_INVESTIGATOR
NCT Number: NCT06432465
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.
Interested in participating?
Request Info21 year–60 year
All sexes
Interventional
Not applicable
Providence, Rhode Island, 02906, United States
Location status: Recruiting
Ana M Abrantes, Ph.D.
CONTACT
Ana M. Abrantes, Ph.D.
PRINCIPAL_INVESTIGATOR
Michael Stein, M.D.
PRINCIPAL_INVESTIGATOR
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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).
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.
Time frame: 2 weeks
Modified Penn Alcohol Craving (0 = no craving to 30 = extreme craving)
Time frame: 2 weeks
theta event rate during working memory task
Time frame: 24 weeks
Timeline Follow back
Contact information is provided by the study sponsor or research team.
Ana M Abrantes, Ph.D.
CONTACT
Julie A Desaulniers, M.S.
CONTACT
Butler Hospital
Other
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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