Buprenorphine Treatment for Opioid Dependence
Information source: Yale University
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Opioid Dependence
Intervention: Buprenorphine (Drug)
Phase: Phase 1/Phase 2
Status: Recruiting
Sponsored by: Yale University Official(s) and/or principal investigator(s):
Elizabeth Ralevski, Ph.D., Principal Investigator, Affiliation: Yale University
Overall contact:
Elizabeth Ralevski, Ph.D., Phone: (203) 932-5711, Ext: 4282, Email: elizabeth.ralevski@yale.edu
Summary
This is a randomized, open-label clinical trial with 200 Veteran opioid dependent men and
women. Veterans will be randomized to one of two treatment groups: low dose range of
buprenorphine (<8mg) vs. high dose range of buprenorphine (<16mg). During induction into
buprenorphine, all participants will be started at a dose of 2mg, and this dose will be
increased as needed for stabilization of opioid withdrawal symptoms, up to 8mg for the low
dose group, and up to 16mg for the high dose group, within a 5 day period. Participants will
be seen on a daily basis (excluding weekends) for the initial 5 day induction. At the end
of the 12-week study, participants will either be referred to a buprenorphine clinic if they
wish to continue this medication, or if they wish to be drug free, will undergo
detoxification from buprenorphine for up to a 4-week period. Follow-up visits, scheduled at
1, 3, and 6 months after study completion, will evaluate the durability of treatment effects
on drug use and psychosocial outcomes. Veterans will be recruited primarily through
advertisement, but also through the clinical facilities at the VA and from other
collaborators.
Clinical Details
Official title: Buprenorphine Treatment for Prescription Opioid Dependence
Study design: Allocation: Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Change in Timeline Follow-Back (TLFB) assessment
Eligibility
Minimum age: 18 Years.
Maximum age: 65 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
1. Males and females between the ages of 18 to 65, current dependence on prescription
opioids as evidenced by documented prior treatment for opioid dependence, signs of
opiate withdrawal as evidenced by a COWS score of 7 or greater, self-reported history
of opioid dependence, and a positive urine toxicology for opiates;
2. willingness to be detoxified from opioids for buprenorphine maintenance ;
3. for women of childbearing age, a negative pregnancy test at screening with agreement
to use adequate contraception to prevent pregnancy, with monthly pregnancy tests
obtained during study participation.
Exclusion Criteria:
1. use of heroin for more than 4 days in the past month;
2. lifetime history of opioid dependence due to heroin alone;
3. ever used heroin intravenously;
4. requirement for current ongoing opioid treatment for adequate pain management;
5. current alcohol, benzodiazepine, barbiturate use with physiologic dependence as
determined during screening history and physical,
6. serious unstable medical illness including bradycardia or other arrhythmias, major
cardiovascular, renal, endocrine, or hepatic disorders for which buprenorphine
treatment is contraindicated or which at the determination of the MD is medically
dangerous;
7. serious psychiatric illness including psychosis, bipolar disorder with psychosis:
8. or significant current suicidal or homicidal thoughts necessitating a higher level or
care;
9. known allergy or intolerance to buprenorphine.
Locations and Contacts
Elizabeth Ralevski, Ph.D., Phone: (203) 932-5711, Ext: 4282, Email: elizabeth.ralevski@yale.edu
VA Connecticut Healthcare System - West Haven Campus, West Haven, Connecticut 06516, United States; Recruiting
Additional Information
Starting date: March 2015
Last updated: July 14, 2015
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