A Within Subject Comparison of Opioid Withdrawal in Opioid Dependent Individuals

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Eric C. Strain, Johns Hopkins University
ClinicalTrials.gov Identifier:
NCT01136356
First received: June 2, 2010
Last updated: May 4, 2013
Last verified: May 2013
  Purpose

Buprenorphine is an approved medication for the treatment of opioid dependence. It is typically administered once daily as a sublingual tablet combined with naloxone (i.e., Suboxone). Evidence suggests buprenorphine produces relatively low levels of physical dependence. In addition, some research suggests there is relatively little withdrawal following cessation of chronically administered buprenorphine. This study will examine the spontaneous withdrawal associated with abrupt cessation of buprenorphine compared to morphine in opioid dependent individuals. This study will assess the characteristics and time course of withdrawal using subject-rated and observer-rated measures of opioid withdrawal. Physiologic measures and psychomotor performance will be collected during chronic opioid administration and during placebo administration (i.e., during spontaneous withdrawal). Particular attention will be paid to the differences (if any) in sleep disturbances and withdrawal associated hyperalgesia.


Condition Intervention Phase
Opioid Abuse
Opioid Dependence
Drug: buprenorphine
Drug: morphine
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Within Subject Comparison of Opioid Withdrawal in Opioid Dependent Individuals

Resource links provided by NLM:


Further study details as provided by Johns Hopkins University:

Primary Outcome Measures:
  • opioid withdrawal assessments [ Time Frame: multiple times throughout day ] [ Designated as safety issue: Yes ]
    standard subject and observer ratings of opioid withdrawal will be collected at multiple time points each day


Secondary Outcome Measures:
  • opioid agonist effects [ Time Frame: multiple times throughout day ] [ Designated as safety issue: Yes ]
    standard observer and subject ratings of opioid agonist effects will be collected at multiple time points each day

  • pain assessments [ Time Frame: 10 times over course of the study ] [ Designated as safety issue: No ]
    a battery of standard pain assessments will be conducted over the approximately 9 weeks of this study

  • sleep measures [ Time Frame: daily ] [ Designated as safety issue: No ]
    standard sleep assessments will be collected each day of the study


Estimated Enrollment: 100
Study Start Date: July 2010
Estimated Study Completion Date: June 2014
Primary Completion Date: March 2012 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: buprenorphine
    parenteral buprenorphine may be administered at multiple times each day
    Drug: morphine
    parenteral morphine may be administered multiple times each day
  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Be adults ranging in age from 21-55 years old.
  • Be dependent on opioids.
  • Be willing to accept or desiring of opioid detoxification.
  • He healthy as determined by medical screen, history, and vitals.
  • Be without significant psychiatric illness besides drug dependence.
  • Be without chronic pain.
  • Fluent in English (speaking, writing, and reading).
  • Be willing and able to participate.

Exclusion Criteria:

  • Previous documented allergy to buprenorphine or morphine.
  • Are dependent on other drugs besides opioids and tobacco.
  • Have current history of significant use of alcohol or sedative/hypnotics.
  • Have evidence of significant medical (e.g., insulin dependent diabetes mellitus) or psychiatric (e.g., schizophrenia) illness.
  • Are pregnant (female volunteers will receive a pregnancy test before participation in the study and routinely during the study).
  • Have an abnormal or prolongation of the QTc interval on a baseline electrocardiogram (ECG).
  • Are seeking treatment for their substance dependence.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01136356

Locations
United States, Maryland
Behavioral Pharmacology Research Unit
Baltimore, Maryland, United States, 21224
Sponsors and Collaborators
Johns Hopkins University
  More Information

No publications provided

Responsible Party: Eric C. Strain, Professor, Johns Hopkins University
ClinicalTrials.gov Identifier: NCT01136356     History of Changes
Other Study ID Numbers: NIDA-08045-9, R01DA008045, DPMC
Study First Received: June 2, 2010
Last Updated: May 4, 2013
Health Authority: United States: Institutional Review Board
United States: Food and Drug Administration

Keywords provided by Johns Hopkins University:
opioid pharmacology
buprenorphine
morphine
withdrawal
human research

Additional relevant MeSH terms:
Buprenorphine
Morphine
Analgesics
Analgesics, Opioid
Central Nervous System Agents
Central Nervous System Depressants
Narcotic Antagonists
Narcotics
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Sensory System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on October 23, 2014