Assessment of Tramadol as a Treatment for Opioid Addiction
NCT ID: NCT00301210
Last Updated: 2015-04-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1/PHASE2
9 participants
INTERVENTIONAL
2006-01-31
2007-11-30
Brief Summary
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Detailed Description
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Participants will be randomly assigned to receive different doses of tramadol or placebo for up to six weeks. Experimental sessions will take place up to three times per week during the treatment period. During challenge sessions, participants will receive an injection; four different kinds of effects may occur in a session following this injection. First, no effect may occur (a placebo). Second, an opioid agonist effect may occur (opioid agonists include heroin, morphine, hydromorphone, tramadol, and methadone), which may cause the participant to feel "high." Third, an opioid antagonist effect may occur (e.g., naloxone, naltrexone), which may cause the participant to feel a sense of opioid withdrawal.
Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
TRIPLE
Study Groups
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1
tramadol dose 1
Tramadol
oral doses four times per day
2
tramadol dose 2
Tramadol
oral doses four times per day
Interventions
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Tramadol
oral doses four times per day
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* History of seizure
* Current sedative or alcohol dependence
* Pregnant or breastfeeding
21 Years
55 Years
ALL
No
Sponsors
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National Institute on Drug Abuse (NIDA)
NIH
Johns Hopkins University
OTHER
Responsible Party
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Eric C. Strain
Professor
Principal Investigators
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Eric C. Strain, MD
Role: PRINCIPAL_INVESTIGATOR
Johns Hopkins University
Locations
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Behavioral Pharmacology Research Unit
Baltimore, Maryland, United States
Countries
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References
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Lanier RK, Lofwall MR, Mintzer MZ, Bigelow GE, Strain EC. Physical dependence potential of daily tramadol dosing in humans. Psychopharmacology (Berl). 2010 Sep;211(4):457-66. doi: 10.1007/s00213-010-1919-3. Epub 2010 Jun 30.
Other Identifiers
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DPMC
Identifier Type: -
Identifier Source: secondary_id
NIDA-18125-2
Identifier Type: -
Identifier Source: org_study_id
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