A Within Subject Comparison of Opioid Withdrawal in Opioid Dependent Individuals

January 11, 2017 updated by: Johns Hopkins University
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

12

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Maryland
      • Baltimore, Maryland, United States, 21224
        • Behavioral Pharmacology Research Unit

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Average mean peak opioid withdrawal thirty minutes before and after injection assessed up to 59 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Average mean daily peak pain ratings assessed from day 0 to day 18 during the 18 day withdrawal period
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.
Average mean peak sleep assessed once a week for up to 8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Johns Hopkins University

Collaborators

National Institute on Drug Abuse (NIDA)

Investigators

  • Principal Investigator: Eric Strain, M.D., Johns Hopkins University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2010

Primary Completion (Actual)

March 1, 2012

Study Completion (Actual)

March 1, 2012

Study Registration Dates

First Submitted

June 2, 2010

First Submitted That Met QC Criteria

June 2, 2010

First Posted (Estimate)

June 3, 2010

Study Record Updates

Last Update Posted (Actual)

March 3, 2017

Last Update Submitted That Met QC Criteria

January 11, 2017

Last Verified

January 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NIDA-08045-9
  • DPMC (Other Identifier: NIDA)
  • R01DA008045 (U.S. NIH Grant/Contract)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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