Table 1.

Prescription Opioid Addiction Treatment Study - General Eligibility Criteria

Inclusion Criteria Ability to read, understand, and provide written informed consent Age ≥ 18 If female and of childbearing potential, agrees to use an acceptable method of birth control throughout study Ability to meet study requirements (i.e., can attend weekly visits, able to take medications, etc.) Meets DSM-IV criteria for current opioid dependence (not simply physically dependent and taking opioids for pain as prescribed) Current physical dependence on opioids (using prescription opioids ≥20 days/month) and need for medical assistance for opioid withdrawal Good general health or, if requires ongoing medical/psychiatric treatment (whether currently in such treatment or not), participant is under the care of a physician willing to continue participant’s medical management and to cooperate with study site investigators Non-psychotic and psychiatrically stable, in the opinion of the study investigator Willingness to provide locator information Prior to induction, participant is in opioid withdrawal (COWS scale > 8) For participants receiving opioids for pain, clearance from their prescribing physician to be withdrawn from their prescribed opioids For participants receiving methadone for pain (those currently receiving methadone treatment for opioid dependence are excluded), dose is ≤ 40 mg

Exclusion criteria A medical condition that would make participation medically hazardous A known allergy or sensitivity to buprenorphine or naloxone An acute severe psychiatric condition or psychosis Participant has been a suicide risk within the past 30 days Dependence on alcohol, sedative-hypnotics or stimulants, and requiring immediate medical attention Participation in another investigational drug study within the last 30 days Participation in methadone or buprenorphine maintenance treatment for opioid dependence within 30 days of study enrollment A current or pending legal status that would make the participant unlikely to remain in the local area for the duration of the study If female, participant is pregnant, lactating, or unwilling to follow study-required measures for pregnancy prevention Inability to remain in the local area for the duration of the study Liver function tests > 5 times the upper limit of normal Surgery scheduled within the next 6 months that would preclude participation during the active treatment phase of the study Current participation in formal substance abuse treatment (other than self-help groups)