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Opioid Efficacy: A Twin-Study

This study is not yet open for participant recruitment.
Verified by Stanford University, May 2008

Sponsors and Collaborators: Stanford University
SRI
Information provided by: Stanford University
ClinicalTrials.gov Identifier: NCT00672438
  Purpose

Proposed twin study will test to what degree inter-individual differences in pain sensitivity and amount of pain relief in response to opioid therapy are inherited or alternatively, are due to environmental factors. This knowledge is important to guide future studies trying to explain such inter-individual differences. For example, finding that differences are largely due to environmental factors would discourage genomic studies and emphasize epidemiological studies.


Condition Intervention
Pain
Drug: Alfentanil

Drug Information available for:   Alfentanil    Alfentanil hydrochloride   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Other, Randomized, Double-Blind, Placebo Control, Crossover Assignment, Pharmacokinetics/Dynamics Study
Official Title:   Opioid Efficacy: A Twin-Study

Further study details as provided by Stanford University:

Primary Outcome Measures:
  • To what degree are inter-individual differences in pain sensitivity and pain relief in response to opioid therapy inherited.

Secondary Outcome Measures:
  • To what degree are inter-individual differences in other effects of opioid medications inherited.

Estimated Enrollment:   250
Study Start Date:   May 2008

  Eligibility
Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes

Criteria

Inclusion Criteria:

  1. Monozygotic or dizygotic twins
  2. Ages 18-70

Exclusion Criteria:

  1. Clinically relevant systemic diseases such as psychiatric, neurological, and dermatological conditions interfering with the collection and interpretation of study data
  2. History of addiction
  3. Allergy to study medication
  4. Chronic intake of medication potentially interfering with pain processing (except oral contraceptives)
  5. Intake of over-the-counter analgesics within the two days prior to study
  6. Reynaud's disease
  7. pregnancy
  8. Participation in other study within last 30 days
  9. Personnel with direct access to addicting drugs
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00672438

Locations
United States, California
Stanford University School of Medicine    
      Stanford, California, United States, 94305

Sponsors and Collaborators
Stanford University
SRI

Investigators
Principal Investigator:     David J. Clark     Stanford University    
Sub-Investigator:     David R. Drover     Stanford University    
Principal Investigator:     Martin S Angst     Stanford University    
  More Information


Study ID Numbers:   SU-04212008-1119, IRB # 13018
First Received:   May 2, 2008
Last Updated:   May 5, 2008
ClinicalTrials.gov Identifier:   NCT00672438
Health Authority:   United States: Institutional Review Board

Study placed in the following topic categories:
Alfentanil
Pain

Additional relevant MeSH terms:
Anesthetics, Intravenous
Physiological Effects of Drugs
Central Nervous System Depressants
Anesthetics
Narcotics
Pharmacologic Actions
Sensory System Agents
Anesthetics, General
Therapeutic Uses
Analgesics
Peripheral Nervous System Agents
Central Nervous System Agents
Analgesics, Opioid

ClinicalTrials.gov processed this record on October 24, 2008




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