CTN - 0051: Extended-Release Naltrexone vs. Buprenorphine for Opioid Treatment (X:BOT)

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Biomarkers (1)

  • EXCLUSION_LFTS - Participant has LFTs greater than 5 times upper limit of normal (phv00498600.v1.p1)

Demographics (6)

Medications (1)

  • EXCLUSION_PAIN - Participant has presence of pain and sufficient severity as to require ongoing pain management with opioids (phv00498604.v1.p1)

Mental Health (5)

  • Affected_status - Opioid Dependence (DSM-5) (phv00498566.v1.p1)
  • EXCLUSION_PSYCH - Participant has a serious medical, psychiatric or substance use disorder that, in the opinion of the study physician, would make study participation hazardous to the participant, or compromise study findings or would prevent the participant from completing the study (phv00498599.v1.p1)
  • EXCLUSION_SUICDE - Participant has suicidal or homicidal ideation that requires immediate attention (phv00498601.v1.p1)
  • INCLUSION_OPIDEP - Participant meets DSM-5 criteria for opioid-use disorder (heroin and/or prescription opioids) (phv00498592.v1.p1)
  • INCLUSION_OPIUSE - Participant has used opioids other than as specifically prescribed within thirty days prior to consent (phv00498593.v1.p1)

Race and Ethnicity (17)

Study Administration (1)

Other (34)

  • ANALYTE_TYPE - Analyte type (phv00498612.v1.p1)
  • BODY_SITE - Body site where sample was collected (phv00498611.v1.p1)
  • CONSENT - Consent group as determined by DAC (phv00498551.v1.p1)
  • CTN_subject_id - CTN Repository subject id: linking id to Clinical Trials Network full clinic data (phv00498609.v1.p1)
  • DERACEDK - Race don't know (phv00498587.v1.p1)
  • DERACEOT - Any other race (phv00498586.v1.p1)
  • DERACERF - Race refused (phv00498588.v1.p1)
  • EXCLUSION_ALERGY - Participant has a known allergy or sensitivity to buprenorphine, naloxone, naltrexone, polylactide-co-glycolide, carboxymethylcellulose, por other components of the Vivitrol diluent (phv00498602.v1.p1)
  • EXCLUSION_HABTUS - Participant has a body habitus that, in the judgment of the study physician, precludes safe intramuscular injection of XR-NTX (phv00498607.v1.p1)
  • EXCLUSION_LEGAL - Participant has pending legal action or other reasons that might prevent an individual from completing the study (phv00498605.v1.p1)
  • EXCLUSION_MTDMNT - Participant is on maintenance of methadone at doses of 30 mg or greater at the time of signing consent (phv00498603.v1.p1)
  • EXCLUSION_PREGNT - Participant is female of child bearing potential and currently pregnant, breastfeeding, or planning on conception (phv00498606.v1.p1)
  • FAMILY_ID - Family ID (phv00498555.v1.p1)
  • FATHER - Father's Subject ID (phv00498557.v1.p1)
  • GENOTYPING_CENTER - Name of the center which conducted genotyping (phv00498614.v1.p1)
  • INCLUSION_BCUSE - Participant is female of childbearing potential, and agrees to use acceptable birth control methods during participation in the study (phv00498595.v1.p1)
  • INCLUSION_ENGLSH - Participant is able to speak English suffiently to understand the study procedures and provide written informed consent to participate in the study (phv00498598.v1.p1)
  • INCLUSION_HEALTH - Participant is in good enough health, as determined by the study physician on the basis of medical history, review of systems, physical exam and laboratory assessments, to permit treatment with XR-NTX or BUP-NX (phv00498596.v1.p1)
  • INCLUSION_INFORM - Participant is able to provide written informed consent (phv00498597.v1.p1)
  • INCLUSION_SEEKTX - Participant is seeking treatment for opioid dependence or is not willing to accept "agonist-based" or "antagonist-based" therapy (phv00498594.v1.p1)
  • IS_TUMOR - Tumor status (phv00498613.v1.p1)
  • MOTHER - Mother's Subject ID (phv00498558.v1.p1)
  • NIDA_subject_id - NIDA Repository subject id (phv00498608.v1.p1)
  • R1NCMPSP - Specify why the participant did not complete the screening visit (phv00498589.v1.p1)
  • R1NORSP - Specify why the participant will not be randomized (phv00498590.v1.p1)
  • SAMPLE_ID - De-identified Sample ID (phv00498610.v1.p1)
  • SAMPLE_ID - Sample ID (phv00498561.v1.p1)
  • SOURCE_SUBJECT_ID - Subject ID used in the Source Repository (phv00498554.v1.p1)
  • Study - NIDA study number (phv00498563.v1.p1)
  • SUBJECT_ID - Subject ID (phv00498562.v1.p1)
  • SUBJECT_ID - Subject ID (phv00498550.v1.p1)
  • SUBJECT_ID - Subject ID (phv00498556.v1.p1)
  • SUBJECT_ID - Subject ID (phv00498560.v1.p1)
  • SUBJECT_SOURCE - Source repository where subjects originate (phv00498553.v1.p1)