The Discriminative Effects of Tramadol in Humans (NCT00499746) | Clinical Trial Compass
CompletedPhase 1/2
The Discriminative Effects of Tramadol in Humans
United States20 participantsStarted 2007-11
Plain-language summary
This research is part of a set of studies whose purpose is to test whether tramadol can be used for the treatment of opioid addiction. Tramadol is already available in the United States as a pain medicine marketed as Ultram. It has effects similar to morphine, and it may also have effects similar to other drugs like stimulants. The doses of tramadol used in this study are higher than those generally used for the treatment of pain. To be in this study a participant must be a user of opioids (drugs like heroin) and stimulants (drugs like cocaine), but cannot be addicted to either. The person must be between 21-55 years old, and generally healthy. Up to 12 people will take part in this study.
Who can participate
Age range
21 Months – 55 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Study subjects are male and female non-dependent opioid users with active stimulant use.
* Between the ages of 21-55
* In good physical health
* Without significant psychiatric illness besides their drug use.
* Females are required to provide a negative pregnancy test prior to study participation.
Exclusion Criteria:
* Subjects are excluded if they have evidence of significant medical (e.g., insulin dependent diabetes mellitus) or psychiatric (e.g., schizophrenia) illness.
* Subjects with a history of seizures will be excluded.
* Persons with current history of significant alcohol or sedative/hypnotic drug use will be excluded from study participation.
* Applicants seeking treatment for their substance abuse will not be admitted to the study, and will be provided information about treatment services available.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Acquisition of Discrimination Assessed by Accuracy of the Discrimination Test
Timeframe: 1 day
2
Discrimination Effects Assessed by Operant Responses
Timeframe: 1 day
3
Discrimination Effects Assessed by Point Distribution
Timeframe: 1day
4
Discrimination Effects Assessed by Discrete Choice