A Within Subject Comparison of Opioid Withdrawal in Opioid Dependent Individuals
This study is ongoing, but not recruiting participants.
Sponsor:
Johns Hopkins University
Collaborator:
Information provided by (Responsible Party):
Eric C. Strain, Johns Hopkins University
ClinicalTrials.gov Identifier:
NCT01136356
First received: June 2, 2010
Last updated: May 4, 2013
Last verified: May 2013
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Opioid Abuse Opioid Dependence |
Drug: buprenorphine Drug: morphine |
Phase 1 Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Pharmacodynamics Study Intervention Model: Crossover Assignment Masking: Double Blind (Subject, Caregiver, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | A Within Subject Comparison of Opioid Withdrawal in Opioid Dependent Individuals |
Resource links provided by NLM:
Further study details as provided by Johns Hopkins University:
Primary Outcome Measures:
- opioid withdrawal assessments [ Time Frame: multiple times throughout day ] [ Designated as safety issue: Yes ]standard subject and observer ratings of opioid withdrawal will be collected at multiple time points each day
Secondary Outcome Measures:
- opioid agonist effects [ Time Frame: multiple times throughout day ] [ Designated as safety issue: Yes ]standard observer and subject ratings of opioid agonist effects will be collected at multiple time points each day
- pain assessments [ Time Frame: 10 times over course of the study ] [ Designated as safety issue: No ]a battery of standard pain assessments will be conducted over the approximately 9 weeks of this study
- sleep measures [ Time Frame: daily ] [ Designated as safety issue: No ]standard sleep assessments will be collected each day of the study
| Estimated Enrollment: | 100 |
| Study Start Date: | July 2010 |
| Estimated Study Completion Date: | June 2014 |
| Primary Completion Date: | March 2012 (Final data collection date for primary outcome measure) |
Intervention Details:
-
Drug: buprenorphine
parenteral buprenorphine may be administered at multiple times each day
Drug: morphine
parenteral morphine may be administered multiple times each day
Eligibility| Ages Eligible for Study: | 18 Years to 60 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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 QTc interval on a baseline electrocardiogram (ECG).
- Are seeking treatment for their substance dependence.
Contacts and Locations More Information
No publications provided
| Responsible Party: | Eric C. Strain, Professor, Johns Hopkins University |
| ClinicalTrials.gov Identifier: | NCT01136356 History of Changes |
| Other Study ID Numbers: | NIDA-08045-9, R01DA008045, DPMC |
| Study First Received: | June 2, 2010 |
| Last Updated: | May 4, 2013 |
| Health Authority: | United States: Institutional Review Board United States: Food and Drug Administration |
Keywords provided by Johns Hopkins University:
|
opioid pharmacology buprenorphine morphine withdrawal human research |
Additional relevant MeSH terms:
|
Opioid-Related Disorders Substance-Related Disorders Mental Disorders Buprenorphine Morphine Analgesics, Opioid Analgesics Sensory System Agents |
Peripheral Nervous System Agents Physiological Effects of Drugs Pharmacologic Actions Central Nervous System Agents Therapeutic Uses Central Nervous System Depressants Narcotic Antagonists Narcotics |
ClinicalTrials.gov processed this record on May 19, 2013