A Phase 2 interventional study of Buprenorphine in Heroin Dependence, Opioid-Related Disorders and Substance Abuse, Intravenous, sponsored by Yale University. Completed at 1 site in United States. Open to participants aged 21 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-06-29.
Sponsored by Yale University · Phase 2, Interventional, and Treatment
The purpose of this study is to compare the Standard Medical Management (SMM) vs. SMM enhanced with additional education about addiction and recovery (Enhanced Medical Management, EMM)
A randomized trial, in a hospital primary care clinic, for 24 weeks, of 168 opioid-dependent subjects, maintained on buprenorphine 3x/week, and counseled with Standard or Enhanced Medical Management. SMM is a brief intervention similar to that provided by primary practitioners to patients with chronic medical conditions such as diabetes. EMM is an intervention that provides education about the recovery process and advice about lifestyle changes and 12-step participation. Outcome measures include reduction in opioid use and abstinence from opioids, documented by 3x/week urine testing and self report.
90 studies on the registry are indexed under Heroin Dependence; 1 is open to participants now.
Browse Heroin Dependence studies →Yale University is the lead sponsor of 1,770 studies on the registry; 294 are open to participants now.
Of its 221 completed or terminated interventional studies of FDA-regulated products, 129 (58%) have results posted.
Counted across the registry records on this site, refreshed daily.
Inclusion criteria: Subjects meeting FDA criteria for opioid agonist maintenance treatment and criteria for opioid dependence will be eligible for the study. Women of childbearing age will be included provided they agree to adequate and to monthly pregnancy monitoring throughout the study.
Exclusion criteria include: pregnancy, current dependence on alcohol, benzodiazepines or sedatives; current suicide or homicide risk; current psychotic disorder or major depression; inability to read or understand English; life-threatening or unstable medical problems.
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.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
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.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Standard Medical Management with once-weekly medication dispensing
Drug: Buprenorphine
Standard Medical Management with thrice-weekly medication dispensing
Drug: Buprenorphine
Enhanced Medical Management with thrice-weekly medication dispensing
Drug: Buprenorphine
1. Experimental Standard Medical Management with once-weekly medication dispensing 2. Experimental Standard Medical Management with thrice-weekly medication dispensing 3. Experimental Enhanced Medical Management with thrice-weekly medication dispensing
Self-reported frequency of illicit opioid use
Time frame: 6 months
Percentage of opioid-negative urine specimens
Time frame: 6 months
Maximum number of weeks abstinent from illicit opioids
Time frame: 6 months
The record gives a start of Aug 2000, a primary completion of Dec 2003 and a completion of Feb 2004. It does not say whether these dates are actual or estimated.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Jun 2020. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Buprenorphine