The Discriminative Effects of Tramadol in Humans

NCT00499746 | Completed Phase 1 Results

• 3 other identifiers: NIDA-18125-3R01DA018125DPMCDA
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Opioid Abuse; Opioid Addiction; Stimulant Abuse; Stimulant Addiction

Keywords

drug discrimination; opioid pharmacology; behavioral pharmacology; human research

Outcome Measures

Primary Outcomes (4)

• Acquisition of Discrimination Assessed by Accuracy of the Discrimination Test

  The acquisition of discrimination was to test whether volunteers could identify each training drug condition by the correct letter code. Results are the percentage of correct responses with a range of 0% to 100%.

  1 day

• Discrimination Effects Assessed by Operant Responses

  Volunteers emitted operant responses on computer keys that corresponded to the training letter, on a fixed interval 1 second schedule for 8.5 minutes. The range is from 0 to 500 operant responses.

  1 day

• Discrimination Effects Assessed by Point Distribution

  In point distribution, volunteers distributed 50 points among three training drug letters depending on how certain they were of the identity of the administrated drug. Maximum total is 50 points.

  1day

• Discrimination Effects Assessed by Discrete Choice

  During discrete choice, volunteers were given three choices (placebo, hydromorphone, methylphenidate) and were asked to choose which of the training drugs they thought they received. The outcome measure illustrates the percentage of participants who chose either placebo, hydromorphone, or methylphenidate during each drug condition (i.e., Placebo, Hydromorphone 8 mg, Tramadol 50 mg, etc.), ranging from 0-100. The outcome measure represents the percentage of participants who chose either placebo, opioid agonist, or stimulant across each drug condition.

  1 day

Secondary Outcomes (4)

• Physiologic Effects Assessed by the Pharmacological Class Questionnaire

  Measure at 120 min after drug administration

• Physiological Effects Assessed by Peak Change From Baseline Pupil Diameter

  Measure at 120 min after drug administration

• Peak Change From Baseline Opioid Agonist Effects Assessed by the Visual Analog Scale (VAS)

  Measure at 120 min after drug administration

• Peak Change From Baseline Stimulant Effects Assessed by the Visual Analog Scale (VAS)

  Measure at 120 min after drug administration

Study Arms (4)

Tramadol

ACTIVE COMPARATOR

oral dose, once per day

Drug: tramadol

Placebo

PLACEBO COMPARATOR

oral dose, once per day

Drug: placebo

hydromorphone

ACTIVE COMPARATOR

oral dose, once per day

Drug: Hydromorphone

methylphenidate

ACTIVE COMPARATOR

oral dose, once per day

Drug: Methylphenidate

Interventions

tramadol DRUG

oral dose, once per day

Also known as: Ultram

Tramadol

placebo DRUG

oral dose, once per day

Also known as: sugar pill

Placebo

Hydromorphone DRUG

oral dose, once per day

Also known as: Dilaudid

hydromorphone

Methylphenidate DRUG

oral dose, once per day

Also known as: stimulant

methylphenidate

Eligibility Criteria

• Age: 21 Months - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• National Institute on Drug Abuse (NIDA): lead

Study Sites (1)

Behavioral Pharmacology Research Unit

Baltimore, Maryland, 21224, United States

Location

Related Publications (1)

• Duke AN, Bigelow GE, Lanier RK, Strain EC. Discriminative stimulus effects of tramadol in humans. J Pharmacol Exp Ther. 2011 Jul;338(1):255-62. doi: 10.1124/jpet.111.181131. Epub 2011 Apr 5.

  PMID: 21467190 RESULT

MeSH Terms

Conditions

Opioid-Related Disorders

Interventions

Tramadol; Sugars; Hydromorphone; Methylphenidate; Central Nervous System Stimulants

Condition Hierarchy (Ancestors)

Narcotic-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Cyclohexanols; Hexanols; Fatty Alcohols; Alcohols; Organic Chemicals; Dimethylamines; Methylamines; Amines; Lipids; Carbohydrates; Morphine Derivatives; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds; Phenylacetates; Acids, Carbocyclic; Carboxylic Acids; Piperidines; Heterocyclic Compounds, 1-Ring; Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses; Central Nervous System Agents; Therapeutic Uses

Results Point of Contact

• Title: Eric C. Strain, M.D.
• Organization: Johns Hopkins University School of Medicine

ecsgss@aol.com

410-550-1191

Study Officials

• Eric C Strain, M.D.

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: NIH
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: July 9, 2007
• First Posted: July 11, 2007
• Study Start: November 1, 2007
• Primary Completion: April 1, 2010
• Study Completion: August 1, 2011
• Last Updated: October 17, 2017
• Results First Posted: October 17, 2017

Record last verified: 2017-09

Locations

US (1)