Phase 2
N=20
The Discriminative Effects of Tramadol in Humans
Opioid Abuse · Opioid Addiction · Stimulant Abuse · Stimulant Addiction
Bottom Line
View on ClinicalTrials.gov: NCT00499746 ↗Enrolled (actual)
20
Serious AEs
0.0%
Results posted
Oct 2017
Primary outcome: Primary: Acquisition of Discrimination Assessed by Accuracy of the Discrimination Test — 87; 87.5; 90 percent of correct response
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- tramadol (Drug); placebo (Drug); Hydromorphone (Drug); Methylphenidate (Drug)
- Age
- Pediatric, Adult · 0+ yrs
- Sex
- All
- Sponsor
- National Institute on Drug Abuse (NIDA)
- Primary completion
- Apr 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Acquisition of Discrimination Assessed by Accuracy of the Discrimination Test |
87; 87.5; 90 | — |
| PRIMARY Discrimination Effects Assessed by Operant Responses |
455.5; 116.6; 0.0; 0.0; 0.0; 464.1 | — |
| PRIMARY Discrimination Effects Assessed by Point Distribution |
50.0; 11.9; 0.0; 0.0; 0.0; 50.0 | — |
| PRIMARY Discrimination Effects Assessed by Discrete Choice |
100; 25; 0; 0; 0; 100 | — |
| SECONDARY Physiologic Effects Assessed by the Pharmacological Class Questionnaire |
100; 25; 0; 0; 0; 100 | — |
| SECONDARY Physiological Effects Assessed by Peak Change From Baseline Pupil Diameter |
-0.5; -1.2; -1.9; -0.6; -0.3; -0.5 | — |
| SECONDARY Peak Change From Baseline Opioid Agonist Effects Assessed by the Visual Analog Scale (VAS) |
1.4; 2.9; 4.8; 2.1; 3.4; 0.4 | — |
| SECONDARY Peak Change From Baseline Stimulant Effects Assessed by the Visual Analog Scale (VAS) |
1.4; 3.6; 3.6; 8.0; 10.6; 0.6 | — |
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.
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT00499746). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.