This trial is active, not recruiting.

Conditions opioid abuse, opioid dependence
Treatments buprenorphine, morphine
Phase phase 1/phase 2
Sponsor Johns Hopkins University
Collaborator National Institute on Drug Abuse (NIDA)
Start date July 2010
End date March 2012
Trial size 100 participants
Trial identifier NCT01136356, DPMC, NIDA-08045-9, R01DA008045


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.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Endpoint classification pharmacodynamics study
Intervention model single group assignment
Masking double blind (subject, caregiver, outcomes assessor)
Primary purpose treatment
parenteral buprenorphine may be administered at multiple times each day
parenteral morphine may be administered multiple times each day

Primary Outcomes

opioid withdrawal assessments
time frame: multiple times throughout day

Secondary Outcomes

opioid agonist effects
time frame: multiple times throughout day
pain assessments
time frame: 10 times over course of the study
sleep measures
time frame: daily

Eligibility Criteria

Male or female participants from 18 years up to 60 years old.

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.

Additional Information

Official title A Within Subject Comparison of Opioid Withdrawal in Opioid Dependent Individuals
Principal investigator Eric Strain, M.D.
Trial information was received from ClinicalTrials.gov and was last updated in April 2015.
Information provided to ClinicalTrials.gov by Johns Hopkins University.