Clinical trial NCT01136356: A Within Subject Comparison of Opioid Withdrawal in Opioid Dependent Individuals
Official title: A Within Subject Comparison of Opioid Withdrawal in Opioid Dependent Individuals
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Opioid Abuse
Opioid Dependence
Keywords: opioid pharmacology
buprenorphine
morphine
withdrawal
human research
Lead sponsor: Johns Hopkins University
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
First posted: 2010-06-03
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility 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.

Primary outcomes:
measure: Mean Peak Opioid Withdrawal Assessed by the Clinical Opiate Withdrawal Scale (COWS)
timeFrame: Average mean peak opioid withdrawal thirty minutes before and after injection assessed up to 59 days
Secondary outcomes:
measure: Mean Daily Peak Pain Ratings Assessed by the Visual Analog Scale (VAS)
timeFrame: Average mean daily peak pain ratings assessed from day 0 to day 18 during the 18 day withdrawal period
measure: Mean Peak Sleep Assessed by Pittsburgh Sleep Quality Index (PSQI)
timeFrame: Average mean peak sleep assessed once a week for up to 8 weeks
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Behavioral Pharmacology Research Unit
state: Maryland
Study officials:
affiliation: Johns Hopkins University
name: Eric Strain, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Tompkins DA, Smith MT, Mintzer MZ, Campbell CM, Strain EC. A double blind, within subject comparison of spontaneous opioid withdrawal from buprenorphine versus morphine. J Pharmacol Exp Ther. 2014 Feb;348(2):217-26. doi: 10.1124/jpet.113.209478. Epub 2013 Nov 13.