Heritability of Opioid Effects: A Twin Study

This study is ongoing, but not recruiting participants.

First Received on May 2, 2008. Last Updated on July 6, 2010 History of Changes

Sponsor:	Stanford University
Collaborator:	SRI International
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:	Allocation: Randomized Endpoint Classification: Pharmacokinetics/Dynamics Study Intervention Model: Crossover Assignment Masking: Double-Blind
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. [ Time Frame: 3 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

To what degree are inter-individual differences in other effects of opioid medications inherited. [ Time Frame: 3 years ] [ Designated as safety issue: No ]

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

Locations

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

Sponsors and Collaborators

Stanford University

SRI International

Investigators

Principal Investigator:

Martin S Angst

Stanford University

More Information

No publications provided

Responsible Party:	Martin S Angst, Stanford University School of Medicine
ClinicalTrials.gov Identifier:	NCT00672438 History of Changes
Other Study ID Numbers:	SU-04212008-1119, IRB # 13018
Study First Received:	May 2, 2008
Last Updated:	July 6, 2010
Health Authority:	United States: Institutional Review Board

Additional relevant MeSH terms:

Alfentanil
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Analgesics

Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses
Anesthetics, Intravenous
Anesthetics, General
Anesthetics

ClinicalTrials.gov processed this record on February 09, 2012