Tramadol to Reduce Opioid Withdrawal Symptoms

Status Completed

Clinical Trial Summary

Individuals with opioid addiction often experience serious withdrawal symptoms that may make relapse unavoidable. Tramadol, a medication that is currently used to treat pain caused by chronic conditions such as cancer or joint pain, may also be effective at reducing opioid withdrawal symptoms. This study will evaluate the effectiveness of tramadol at reducing withdrawal symptoms in individuals addicted to opioid drugs.

Clinical Trial Description

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. ;

Study Design

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

Related Conditions & MeSH terms

Opioid-Related Disorders

Clinical Trial Details

NCT number	NCT00142896
Study type	Interventional
Source	National Institute on Drug Abuse (NIDA)
Contact
Status	Completed
Phase	Phase 2
Start date	February 2005
Completion date	December 2005

View Details

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.