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

This study has been completed.
Sponsor:
Information provided by:
Reckitt Benckiser Pharmaceuticals Inc.
ClinicalTrials.gov Identifier:
NCT00637000
First received: March 10, 2008
Last updated: October 20, 2008
Last verified: October 2008
  Purpose

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.


Condition Intervention Phase
Opioid-Related Disorders
Drug: Buprenorphine
Drug: Buprenorphine/Naloxone
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Induction of Opioid-Dependent Individuals Onto Buprenorphine and Buprenorphine/Naloxone

Resource links provided by NLM:


Further study details as provided by Reckitt Benckiser Pharmaceuticals Inc.:

Primary Outcome Measures:
  • Severity of withdrawal symptoms measured using the Clinical Opiate Withdrawal Scale [ Time Frame: During the first two days of induction treatment ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Adverse Events [ Time Frame: During active treatment ] [ Designated as safety issue: Yes ]
  • Clinical Laboratory Measures [ Time Frame: On completion of treatment ] [ Designated as safety issue: Yes ]
  • Electrocardiogram changes [ Time Frame: On completion of treatment ] [ Designated as safety issue: Yes ]
  • Vital signs [ Time Frame: During Active Treatment ] [ Designated as safety issue: Yes ]
  • Pupil diameter changes [ Time Frame: During Active Treatment ] [ Designated as safety issue: Yes ]
  • Visual Analog Scales Scores for Withdrawal Symptoms [ Time Frame: During Active Treatment ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 50
Study Start Date: February 2008
Study Completion Date: October 2008
Primary Completion Date: October 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Buprenorphine
Drug: Buprenorphine
2 mg and 8 mg with doses escalated from 12 mg per day up to 24 mg daily for 5 days
Experimental: 2
Buprenorphine/Naloxone
Drug: Buprenorphine/Naloxone
2 mg/0.5 mg buprenorphine/naloxone and 8 mg/2 mg buprenorphine/naloxone at doses of 12/3 mg up to 24/6 mg daily for 5 days

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00637000

Locations
United States, Maryland
Johns Hopkins University School of Medicine
Baltimore, Maryland, United States, 21224
Sponsors and Collaborators
Reckitt Benckiser Pharmaceuticals Inc.
Investigators
Principal Investigator: Eric C. Strain, M.D. Johns Hopkins University
  More Information

No publications provided

Responsible Party: Rolley E. Johnson, Pharm.D./Vice-President, Clinical, Scientific & Regulatory Affairs, Reckitt Benckiser Pharmaceuticals Inc
ClinicalTrials.gov Identifier: NCT00637000     History of Changes
Other Study ID Numbers: RB-US-07-0002
Study First Received: March 10, 2008
Last Updated: October 20, 2008
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board

Keywords provided by Reckitt Benckiser Pharmaceuticals Inc.:
Opioid dependence
Opioid withdrawal symptoms

Additional relevant MeSH terms:
Opioid-Related Disorders
Substance-Related Disorders
Mental Disorders
Buprenorphine
Analgesics, Opioid
Naloxone
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Central Nervous System Depressants
Narcotic Antagonists
Narcotics

ClinicalTrials.gov processed this record on April 15, 2014