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. 2022 Oct 18;30:101018. doi: 10.1016/j.conctc.2022.101018

Table 2.

Participant selection criteria.

Inclusion Criteria Exclusion Criteria
  • (1)

    Meet DSM-5 criteria for opioid use disorder (any severity level) alone or comorbid with stable medical diseases (except for certain medications below)

  • (1)

    Acute/unstable illness: conditions making it unsafe to participate

  • (2)

    Stated desire to be opioid abstinent without medication for opioid use disorder

  • (2)

    Chronic illnesses: primarily seizures and dementing illnesses, including medications for these neurological conditions

  • (3)

    Initiating opioid discontinuation at study site

  • (3)

    Current serious psychiatric disease: psychosis, bipolar disorder

  • (4)

    In good general health as evidenced by medical history

  • (4)

    Current requirement to detoxify for alcohol or benzodiazepines

  • (5)

    Male or female, aged 18–65 years

  • (5)

    Current use of anxiolytics, hypnotics (prescription and over-the-counter), antidepressants, anticonvulsants, sedating H1 antihistamines (non-sedating second generation H4 antihistamines are allowed), prescription and over-the-counter stimulants

  • (6)

    Provision of signed and dated informed consent and HIPAA authorization form

  • (6)

    Current diagnosis other than opioid use disorder requiring chronic opioid treatment

  • (7)

    Stated willingness to comply with all study procedures and availability for the duration of the study (including inpatient stay and participation in video assessments and remote drug screens for the duration of the 12-week outpatient study period)

  • (7)

    Presence of a cardiac pacemaker

  • (8)

    Use of highly effective contraception for at least 1 month prior to screening and agreement to use such a method for the duration of the study

  • (8)

    Pregnancy or lactation. Females who do not agree to sexual abstinence or are heterosexually active and not using (self-report) medically approved birth control measures (sterilization, tubal ligation, oral/depot contraceptives, abstinence, intrauterine device, barrier method such as condom/foam, or a cervical cap combined with a spermicide), are not eligible

  • (9)

    treatment will not commence until the Clinical Opiate Withdrawal Scale total score is 13 or greater (at least moderate withdrawal); thus, a consented participant could be dis-enrolled

  • (9)

    Receiving extended-release buprenorphine within 300 days of enrollment