Clinical trial NCT00023283: Counseling Conditions for Buprenorphine in a Primary Care Clinic - 1
Official title: Counseling Conditions for Thrice Weekly Buprenorphine in a Primary Care Clinic
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Heroin Dependence
Opioid-Related Disorders
Substance Abuse, Intravenous
Keywords: Opioid-Related Disorders
Lead sponsor: Yale University
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
First posted: 2001-08-31
Sex: ALL
Minimum age (years): 21
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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)

Detailed description: 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.

Eligibility criteria: Inclusion criteria: Subjects meeting FDA criteria for opioid agonist maintenance treatment and DSM-IV criteria for opioid dependence will be eligible for the study. Women of childbearing age will be included provided they agree to adequate contraception 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.

Primary outcomes:
measure: Self-reported frequency of illicit opioid use
timeFrame: 6 months
measure: Percentage of opioid-negative urine specimens
timeFrame: 6 months
measure: Maximum number of weeks abstinent from illicit opioids
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: New Haven
country: United States
facility: APT Residential Services Division
state: Connecticut
Study officials:
affiliation: Yale University
name: Richard Schottenfeld, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Sullivan LE, Moore BA, Chawarski MC, Pantalon MV, Barry D, O'Connor PG, Schottenfeld RS, Fiellin DA. Buprenorphine/naloxone treatment in primary care is associated with decreased human immunodeficiency virus risk behaviors. J Subst Abuse Treat. 2008 Jul;35(1):87-92. doi: 10.1016/j.jsat.2007.08.004. Epub 2007 Oct 15.
citation: Fiellin DA, Pantalon MV, Chawarski MC, Moore BA, Sullivan LE, O'Connor PG, Schottenfeld RS. Counseling plus buprenorphine-naloxone maintenance therapy for opioid dependence. N Engl J Med. 2006 Jul 27;355(4):365-74. doi: 10.1056/NEJMoa055255.