Clinical trial NCT02187198: Buprenorphine Treatment for Opioid Dependence
Official title: Buprenorphine Treatment for Prescription Opioid Dependence
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Opioid Dependence
Keywords: Opioid Dependence
Buprenorphine
Lead sponsor: Yale University
Sponsor class: OTHER
Collaborators: name: United States Department of Defense
First posted: 2014-07-10
Enrollment: 9
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Buprenorphine/naloxone (BUP/NLX) treatment is effective for the treatment of prescription opioid dependence, previous studies have not determined the optimum dose of BUP/NLX for this patient population. The goal of this study is to determine if there are differences in clinical efficacy of BUP/NLX tablet in low dose range (less than or equal to 8/2mg) vs. high dose range (greater than or equal to 16, range 16-24mg). The main outcomes of interest will be treatment retention, use of opioids, and the use of other drugs of abuse.

Detailed description: This is a randomized, open-label clinical trial with approximately 9 Veteran opioid dependent men and women. Veterans were randomized to one of two treatment groups: low dose range of buprenorphine (\<8mg) vs. high dose range of buprenorphine/naloxone (BUP/NLX (\<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.

Eligibility 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 Clinical Opiate Withdrawal Scale 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.

Primary outcomes:
measure: Urine Toxicology for Opiate Use
timeFrame: Weeks 1-12
measure: Urine Toxicology
timeFrame: Weeks 1-12
Secondary outcomes:
Other outcomes:
Locations:
city: West Haven
country: United States
facility: VA Connecticut Healthcare System - West Haven Campus
state: Connecticut
Study officials:
affiliation: Yale University
name: Elizabeth Ralevski, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: