Assessment of Tramadol as a Treatment for Opioid Addiction

• Register: ClinicalTrials.gov
• Last refreshed on: 18 March 2013
• Main ID: NCT00301210
• Date of registration: 09/03/2006
• Primary sponsor: Johns Hopkins University
• Public title: Assessment of Tramadol as a Treatment for Opioid Addiction
• Scientific title: Assessment of the Level of Physical Dependence and Blockade Efficacy Produced by Tramadol
• Date of first enrolment: January 2006
• Target sample size: 9
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT00301210
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Outcomes Assessor), Primary Purpose: Treatment

Countries of recruitment

United States

Contacts

• Name: Eric C. Strain, MD
• Affiliation: Johns Hopkins University

Key inclusion & exclusion criteria

Inclusion Criteria:

- Currently opioid dependent

Exclusion Criteria:

- Significant medical illness (e.g., diabetes mellitus)

- History of seizure

- Current sedative or alcohol dependence

- Pregnant or breastfeeding



Age minimum: 21 Years
Age maximum: 55 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Opioid-Related Disorders

Intervention(s)

Drug: Tramadol

Primary Outcome(s)

cognitive/performance measures [Time Frame: up to 4 hours for acute effects]

observer ratings of effects [Time Frame: up to 4 hours for acute effects]

physiologic measures [Time Frame: up to 4 hours for acute effects]

Self-reported effects [Time Frame: up to 4 hours for acute effects]

Secondary ID(s)

DPMC

NIDA-18125-2

R01DA018125-02

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

National Institute on Drug Abuse (NIDA)