Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 10:56 PM
Ignite Modification Date:
2025-12-24 @ 10:56 PM
NCT ID:
NCT03653169
Eligibility Criteria:
Inclusion Criteria:
* Aged 18-65 years old
* Initiated treatment with buprenorphine for opioid use disorder within the last 3 months
* Be able to understand, read and write English.
* If female and of childbearing age, agree to use acceptable birth control during the study treatment period (oral contraceptives, history of tubal ligation, history of a hysterectomy, or a reliable barrier method) during the study treatment period.
Exclusion Criteria:
* Lifetime history of bipolar disorder or psychotic disorder,
* Current depression as rated by PHQ-9 ≥ 20 (Kroenke, Spitzer, and Williams 2001, Suzuki et al. 2015)
* Moderate chronic pain (pain intensity rated ≥ 40 on 100-point VAS lasting at least 6 months (Stein et al. 2015)
* History of alcohol use disorder as rated by AUDIT-C ≥ 4 (at risk) (Babor et al. 2001)
* History of complicated withdrawal from alcohol (i.e. delirium tremens, seizure)
* Substance use disorder in the past year (other than opioid or nicotine), as assessed by drug screens,
* Neurologic disease including stroke, seizure, migraine, or severe head injury
* Major medical conditions that are not well-controlled or under the care of a physician
* Device (i.e. pacemaker, cochlear prosthesis, neurostimulator, intraocular metallic fragments) or ferromagnetic implant above the neck (within 30 cm of coil),
* Medication that lowers seizure threshold (i.e. immediate release bupropion, psychostimulants, tricyclic antidepressants) or impairs neuroplasticity (i.e. benzodiazepines)
* Pregnant
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT03653169
Study Brief:
Protocol Section:
NCT03653169