Heritability of Opioid Effects: A Twin Study

This study is currently recruiting participants.

Verified by Stanford University, February 2009

First Received: May 2, 2008 Last Updated: February 12, 2009 History of Changes

Sponsor:	Stanford University
Collaborator:	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

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

Resource links provided by NLM:

Drug Information available for: Alfentanil hydrochloride Alfentanil

U.S. FDA Resources

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
Estimated Primary Completion Date:	June 2011 (Final data collection date for primary outcome measure)

Eligibility

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

Criteria

Inclusion Criteria:Monozygotic or dizygotic twins 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

Contacts

Contact: Nick Phillips, BS, BA, MTOM

(650) 721-6121

nickphillips@stanford.edu

Locations

United States, California
Stanford University School of Medicine	Recruiting
Stanford, California, United States, 94305
Contact: Nick Phillips, BS, BA, MTOM 650-721-6121 nickphillips@stanford.edu
Principal Investigator: David J. Clark
Principal Investigator: Martin S Angst
Sub-Investigator: David R. Drover

Sponsors and Collaborators

Stanford University

SRI

Investigators

Principal Investigator:	David J. Clark	Stanford University
Principal Investigator:	Martin S Angst	Stanford University

More Information

No publications provided

Responsible Party:	( Nick Phillips, BS, BA, MTOM )
Study ID Numbers:	SU-04212008-1119, IRB # 13018
Study First Received:	May 2, 2008
Last Updated:	February 12, 2009
ClinicalTrials.gov Identifier:	NCT00672438 History of Changes
Health Authority:	United States: Institutional Review Board

Additional relevant MeSH terms:

Anesthetics, Intravenous
Physiological Effects of Drugs
Central Nervous System Depressants
Anesthetics
Alfentanil
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 November 09, 2009