Induction of Opioid-Dependent Individuals Onto Buprenorphine and Buprenorphine/Naloxone

Condition(s) targeted: Opioid-Related Disorders

Intervention: Buprenorphine (Drug); Buprenorphine/Naloxone (Drug)

Phase: Phase 2

Status: Recruiting

Sponsored by: Reckitt Benckiser Pharmaceuticals, Inc

Official(s) and/or principal investigator(s):
Eric C. Strain, M.D., Principal Investigator, Affiliation: Johns Hopkins University

Overall contact:
Joseph Harrison, Phone: 410-550-3073, Email: jaharris@jhmi.edu

The purpose of this study is to compare the presence, degree, time course and profile of opioid withdrawal symptoms associated with induction onto new formulations of buprenorphine or buprenorphine/naloxone in persons with active opioid dependence. The primary outcome measure is the severity of withdrawal symptoms measured using the Clinical Opiate Withdrawal Scale. The primary study hypothesis is that neither drug formulation will precipitate an opioid withdrawal syndrome.

Official title: Induction of Opioid-Dependent Individuals Onto Buprenorphine and Buprenorphine/Naloxone

Study design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Parallel Assignment, Safety Study

Primary outcome: Severity of withdrawal symptoms measured using the Clinical Opiate Withdrawal Scale

Secondary outcome:

Adverse Events

Clinical Laboratory Measures

Electrocardiogram changes

Vital signs

Pupil diameter changes

Visual Analog Scales Scores for Withdrawal Symptoms

Minimum age: 18 Years. Maximum age: 65 Years. Gender(s): Both.

Criteria:

Inclusion Criteria:

Subject must:

- Provide written informed consent.

- Have a DSM-IV diagnosis of opioid dependence.

- Be male or female, 18 to 65 years of age, inclusive.

- If female, have a negative pregnancy test during screening and agree to use an

acceptable method of birth control.

Exclusion Criteria:

Subjects must not:

- Have participated in an experimental drug or device study within the last 30 days.

- Be currently (past 30 days from start of screening) engaged in opioid agonist, opioid

partial agonist, or opioid antagonist treatment.

- If female, be breast feeding or lactating.

- Have any medical condition that in the opinion of the physician investigator would

preclude the subject from completing the study.

- Have any clinically significant non-substance use psychiatric disorder (e. g.,

schizophrenia).

- Have current suicidal ideation.

- Have a Mini Mental Status Exam score less than 24.

- Have physical dependence on alcohol.

- Have physical dependence on sedative-hypnotics.

- Have active aphthous stomatitis.

- Have active oral herpes.

- Need on-going prescription medications that interact with the P450 3A4 system.

Joseph Harrison, Phone: 410-550-3073, Email: jaharris@jhmi.edu

Johns Hopkins University School of Medicine, Baltimore, Maryland 21224, United States; Recruiting
Eric C. Strain, MD, Principal Investigator
George E. Bigelow, Ph.D., Sub-Investigator

Starting date: February 2008
Last updated: March 10, 2008