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A Within Subject Comparison of Opioid Withdrawal in Opioid Dependent Individuals

This study has been completed.
Sponsor:
Collaborator:
National Institute on Drug Abuse (NIDA)
Information provided by (Responsible Party):
Johns Hopkins University
ClinicalTrials.gov Identifier:
NCT01136356
First received: June 2, 2010
Last updated: January 11, 2017
Last verified: January 2017
  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
Intervention Model: Crossover Assignment
Masking: Double Blind (Participant, Care Provider, 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:
  • Mean Peak Opioid Withdrawal Assessed by the Clinical Opiate Withdrawal Scale (COWS) [ Time Frame: Average mean peak opioid withdrawal thirty minutes before and after injection assessed up to 59 days ]
    Clinical Opiate Withdrawal Scale (COWS) is an observer-rated tool for quantifying opioid withdrawal. The scale ranges from 0 to 48: Scores 5 to 12 are mild, 13 to 24 are moderate, 25 to 36 are moderately severe, and over 36 are severe withdrawal. The scores on this repeated measure were analyzed by a two-factor ANOVA for mean peak daily COWS ratings.


Secondary Outcome Measures:
  • Mean Daily Peak Pain Ratings Assessed by the Visual Analog Scale (VAS) [ Time Frame: Average mean daily peak pain ratings assessed from day 0 to day 18 during the 18 day withdrawal period ]
    Visual Analog Scale (VAS) measures subjective ratings on pain. The scale on this measurement ranges from 0 being "None" to 100 being "Extremely". The results below reflect the subjective measurements of pain taken from day 0 to day 18 of withdrawal from both morphine and buprenorphine.

  • Mean Peak Sleep Assessed by Pittsburgh Sleep Quality Index (PSQI) [ Time Frame: Average mean peak sleep assessed once a week for up to 8 weeks ]
    Pittsburgh Sleep Quality Index (PSQI) is a self-report questionnaire that assesses sleep quality, total scores range from 0 (better) to 21(worse). The data that has been reported reflects the peak scores on the PSQI during the withdrawal period from both morphine and buprenorphine.


Enrollment: 12
Study Start Date: July 2010
Study Completion Date: March 2012
Primary Completion Date: March 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Morphine, then Buprenorphine
Healthy, out of treatment opioid-dependent residential volunteers (N=7) were randomized to receive morphine (120 mg/day i.m.) administered in four divided doses each day for 9 days (30 mg of morphine four times per day). Participants then underwent an 18-day period of spontaneous opioid withdrawal, during which four double blind i.m. placebo injections were administered daily. After the period of spontaneous withdrawal, participants received buprenorphine (32 mg/day i.m.) administered in four divided doses each day for 9 days (8 mg of buprenorphine four times per day) followed by a second 18-day period of spontaneous withdrawal identical to the withdrawal period described above.
Drug: buprenorphine
parenteral buprenorphine may be administered at multiple times each day
Drug: morphine
parenteral morphine may be administered multiple times each day
Experimental: Buprenorphine, then Morphine
Healthy, out of treatment opioid-dependent residential volunteers (N=7) were randomized to receive buprenorphine (32 mg/day i.m.) administered in four divided doses each day for 9 days (8 mg of buprenorphine four times per day). Participants then underwent an 18-day period of spontaneous withdrawal, during which four double blind i.m. placebo injections were administered daily. After the period of spontaneous withdrawal, participants received morphine (120 mg/day i.m.) administered in four divided doses each day for 9 days (30 mg of morphine four times per day) followed by a second 18-day period of spontaneous withdrawal identical to the withdrawal period described above.
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   (Adult)
Sexes Eligible for Study:   All
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 corrected QT interval (QTc) 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
National Institute on Drug Abuse (NIDA)
Investigators
Principal Investigator: Eric Strain, M.D. Johns Hopkins University
  More Information

Additional Information:
Publications:
Responsible Party: Johns Hopkins University
ClinicalTrials.gov Identifier: NCT01136356     History of Changes
Other Study ID Numbers: NIDA-08045-9
R01DA008045 ( US NIH Grant/Contract Award Number )
DPMC ( Other Identifier: NIDA )
Study First Received: June 2, 2010
Results First Received: April 14, 2016
Last Updated: January 11, 2017

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

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

ClinicalTrials.gov processed this record on June 22, 2017