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A Within Subject Comparison of Opioid Withdrawal in Opioid Dependent Individuals

This study is ongoing, but not recruiting participants.
National Institute on Drug Abuse (NIDA)
Information provided by (Responsible Party):
Eric C. Strain, Johns Hopkins University Identifier:
First received: June 2, 2010
Last updated: April 16, 2015
Last verified: April 2015
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: Intervention Model: Single Group 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 ]
    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 ]
    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 ]
    a battery of standard pain assessments will be conducted over the approximately 9 weeks of this study

  • sleep measures [ Time Frame: daily ]
    standard sleep assessments will be collected each day of the study

Estimated Enrollment: 100
Study Start Date: July 2010
Estimated Study Completion Date: June 2016
Primary Completion Date: March 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: challenge drug Drug: buprenorphine
parenteral buprenorphine may be administered at multiple times each day
Drug: morphine
parenteral morphine may be administered multiple times each day


Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
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Please refer to this study by its identifier: NCT01136356

United States, Maryland
Behavioral Pharmacology Research Unit
Baltimore, Maryland, United States, 21224
Sponsors and Collaborators
Johns Hopkins University
National Institute on Drug Abuse (NIDA)
Principal Investigator: Eric Strain, M.D. Johns Hopkins University
  More Information

Responsible Party: Eric C. Strain, Professor, Johns Hopkins University Identifier: NCT01136356     History of Changes
Other Study ID Numbers: NIDA-08045-9  R01DA008045  DPMC 
Study First Received: June 2, 2010
Last Updated: April 16, 2015

Keywords provided by Johns Hopkins University:
opioid pharmacology
human research

Additional relevant MeSH terms:
Analgesics, Opioid
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Narcotic Antagonists processed this record on February 23, 2017