Withdrawal Suppression Efficacy of Tramadol
Opioid withdrawal symptoms are a major contributing factor for why opioid treatment programs
often fail. Individuals with severe opioid withdrawal symptoms may experience shaking,
muscle and bone pain, nausea, depression, anxiety, and drug craving. Tramadol is a
medication that is currently used to treat moderate to severe pain in individuals with
cancer, joint pain, or pain resulting from surgery. Because of its pharmacological profile,
tramadol may also be useful in treating opioid withdrawal. Further research is needed to
confirm the benefits of tramadol for opioid addicts. The purpose of this study is to
evaluate the effectiveness of tramadol at reducing opioid withdrawal symptoms in
opioid-dependent individuals.
This 6-week inpatient study will enroll opioid-dependent individuals. Participants will be
required to reside at the research clinic for the entire study. All participants will
receive morphine maintenance treatment on a daily basis. Twice a week participants will take
part in experimental challenge sessions in which they will be randomly assigned to receive
varying doses of tramadol, naloxone, morphine, or placebo. These sessions will assess the
ability of tramadol to suppress opioid withdrawal symptoms. Participants will complete
performance tasks to measure psychomotor and cognitive functioning. Heart rate and blood
pressure will be monitored throughout the experimental sessions. A specialized camera will
also be used to assess pupillary response of the eyes. Questionnaires and self-reports will
be completed to assess medication effects and withdrawal symptoms. Following the end of the
study, all participants will be offered outpatient drug abuse treatment.
Interventional
Allocation: Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Crossover Assignment, Masking: Double-Blind, Primary Purpose: Treatment
Opioid withdrawal symptoms (measured by Visual Analog Scale during the experimental sessions)
Eric C. Strain, MD
Principal Investigator
Johns Hopkins University
United States: Food and Drug Administration
NIDA-18125-1
NCT00142896
February 2005
December 2005
Name | Location |
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Johns Hopkins University (BPRU) Bayview Campus | Baltimore, Maryland 21224-6823 |