A Phase 3 interventional study of Buprenorphine/naloxone in Heroin Dependence and Substance-Related Disorders, sponsored by National Institute on Drug Abuse (NIDA). Completed at 1 site in United States. Open to participants aged 18 Years to 59 Years. Per ClinicalTrials.gov, last updated 2017-01-16.
Sponsored by National Institute on Drug Abuse (NIDA) · Phase 3, Interventional, and Treatment
The purpose of this study is the use of buprenorphine/naloxone in treatment of opioid dependence.
The objective of this study is to determine the safety and efficacy of a buprenorphine/naloxone combination tablet for opiate dependence treatment.
90 studies on the registry are indexed under Heroin Dependence; 1 is open to participants now.
Browse Heroin Dependence studies →National Institute on Drug Abuse (NIDA) is the lead sponsor of 393 studies on the registry; 19 are open to participants now.
Of its 14 completed or terminated interventional studies of FDA-regulated products, 6 (43%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
diagnosis of current opiate dependence males and non-pregnant, non-nursing female 18-59 yrs of age
Exclusion Criteria:
Any significant medical condition or ALT levels greater than 3x's the level Current Axis I diagnosis other than opiate, caffeine or nicotine dependence
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
DSM diagnostic criteria
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Drug pages: Buprenorphine · Naloxone
Craving
Drug use
Retention
Opioid withdrawal
Subjective rating
This study is completed, as verified in Jan 1999. You cannot join it, but the record below documents what was studied.
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Studies of the drugs tested here: Buprenorphine · Naloxone
National Institute on Drug Abuse (NIDA) →