Skip to main content
OpenTrials
Completed

NCT Number: NCT01136356

A Within Subject Comparison of Opioid Withdrawal in Opioid Dependent Individuals

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Opioid Abuse Chemically-Induced Disorders Mental Disorders Narcotic-Related Disorders Opioid Dependence Opioid-Related Disorders Substance-Related Disorders

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Behavioral Pharmacology Research Unit

Baltimore, Maryland, 21224, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

buprenorphine

Drug

parenteral buprenorphine may be administered at multiple times each day

Morphine

Drug

parenteral morphine may be administered multiple times each day

Primary outcomes

  1. 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 outcomes

  1. 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.

  2. 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.

Sponsors and collaborators

Lead sponsor

Johns Hopkins University

Other

Collaborators

  • National Institute on Drug Abuse (NIDA)

Registry information

Important dates

Study start
2010
Primary completion
2012
Study completion
2012
First posted
Jun 3, 2010
Registry last updated
Mar 3, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.