Phase 2
N=12
A Within Subject Comparison of Opioid Withdrawal in Opioid Dependent Individuals
Opioid Abuse · Opioid Dependence
Bottom Line
View on ClinicalTrials.gov: NCT01136356 ↗Enrolled (actual)
12
Serious AEs
0.0%
Results posted
Mar 2017
Primary outcome: Primary: Mean Peak Opioid Withdrawal Assessed by the Clinical Opiate Withdrawal Scale (COWS) — 12.6; 1.3 units on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- buprenorphine (Drug); morphine (Drug)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- Johns Hopkins University
- Primary completion
- Mar 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Mean Peak Opioid Withdrawal Assessed by the Clinical Opiate Withdrawal Scale (COWS) |
12.6; 1.3 | — |
| SECONDARY Mean Daily Peak Pain Ratings Assessed by the Visual Analog Scale (VAS) |
6.1; 2; 29.3; 6.3; 51.6; 13.3 | — |
| SECONDARY Mean Peak Sleep Assessed by Pittsburgh Sleep Quality Index (PSQI) |
10.3; 5.5; 11.3; 6.9 | — |
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.
Data sourced from ClinicalTrials.gov (NCT01136356). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.