A Within Subject Comparison of Opioid Withdrawal in Opioid Dependent Individuals

Completed · Phase 1/Phase 2

Conditions studied: Opioid Abuse, Opioid Dependence

In brief

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.

Key facts

Study ID

NCT01136356

Run by

Johns Hopkins University

People needed

12

Starts

2010-07-01

Expected to finish

2012-03-01

Last updated by the study team

2017-03-03

Who can join

Age: 18 and older, up to 60. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

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

Full record on ClinicalTrials.gov

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