The purpose of this study is to see if tramadol can be useful in suppressing opioid withdrawal symptoms in persons who are physically dependent on opioids.

Condition	Intervention	Phase
Opioid Dependence	Drug: Tramadol	Phase II

Further Study Details: 

Primary Outcomes: Opioid withdrawal; Opioid agonist effects; Physiological effects
Expected Total Enrollment:  16

This is a residential human laboratory study that will test the effects of tramadol as a step in the development of this medication as a new treatment for opioid dependence. Tramadol is a mild/moderate mu agonist opioid that should be effective at suppressing the signs and symptoms of spontaneous opioid withdrawal, given its pharmacological profile. If this medication is to be useful in the treatment of opioid dependence, then it is necessary that acute doses of tramadol effectively attenuate withdrawal symptoms. Participants are opioid dependent volunteers with active opioid use who are admitted to the BPRU''''s residential ward for the duration of the active phase of the study. They reside on the ward for approximately six weeks, and are maintained on morphine. Subjects undergo experimental challenge sessions twice per week. These sessions assess the ability of tramadol to suppress spontaneous opioid (morphine) withdrawal.

Ages Eligible for Study:  21 Years   -   55 Years,  Genders Eligible for Study:  Both

Criteria

Inclusion Criteria:

Study subjects are male and female opioid users in good physical health and without significant psychiatric illness besides their drug abuse. They must qualify for treatment with opioid agonist therapy (e.g., methadone), and fulfill a DSM-IV diagnosis of opioid dependence.

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Exclusion Criteria:

Subjects are excluded if they have evidence of significant medical (e.g., insulin dependent diabetes mellitus) or psychiatric (e.g., schizophrenia) illness.

Females are required to provide a negative pregnancy test prior to study participation (and are routinely tested during their study participation). Applicants seeking treatment for their substance abuse will not be admitted to the study, and will be provided information about treatment services available.

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Please refer to this study by ClinicalTrials.gov identifier  NCT00142896

Maryland
      Johns Hopkins University (BPRU) Bayview Campus, Baltimore,  Maryland,  21224 6823,  United States; Recruiting

Study chairs or principal investigators

Eric C Strain, M.D.,  Principal Investigator,  Johns Hopkins University   

Study ID Numbers:  NIDA-18125-1; R01-18125-1
Last Updated:  September 1, 2005
Record first received:  September 1, 2005
ClinicalTrials.gov Identifier:  NCT00142896
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-09-06