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Withdrawal Suppression Efficacy of Tramadol

Phase 2
21 Years
55 Years
Not Enrolling
Opioid-Related Disorders

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Trial Information

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.

Inclusion Criteria:

- Meets DSM-IV diagnostic criteria for opioid dependence

- Is in good physical health

- Qualifies for treatment with opioid agonist therapy (e.g., methadone)

- If female, must have a negative pregnancy test prior to study entry

Exclusion Criteria:

- Evidence of significant medical illness (e.g., insulin dependent diabetes mellitus)

- Evidence of significant psychiatric illness (e.g., schizophrenia)

- Currently seeking treatment for substance abuse

- Pregnant or breastfeeding

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Crossover Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Outcome Measure:

Opioid withdrawal symptoms (measured by Visual Analog Scale during the experimental sessions)

Principal Investigator

Eric C. Strain, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Johns Hopkins University


United States: Food and Drug Administration

Study ID:




Start Date:

February 2005

Completion Date:

December 2005

Related Keywords:

  • Opioid-Related Disorders
  • Opiate Addiction
  • Opiate Dependence
  • Opioid-Related Disorders



Johns Hopkins University (BPRU) Bayview Campus Baltimore, Maryland  21224-6823