Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Heritability of Opioid Effects: A Twin Study

This study has been completed.
Sponsor:
Collaborator:
SRI International
Information provided by (Responsible Party):
Martin Angst, Stanford University
ClinicalTrials.gov Identifier:
NCT00672438
First received: May 2, 2008
Last updated: March 23, 2012
Last verified: March 2012
  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 (Subject, Investigator)
Official Title: Heritability of Opioid Effects: A Twin Study

Resource links provided by NLM:


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 ]

Enrollment: 242
Study Start Date: May 2008
Study Completion Date: June 2010
Primary Completion Date: June 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Alfentanil infusion Drug: Alfentanil
Target steady state infusion of alfentanil at a plasma concentration of 100ng/ml
Placebo Comparator: Saline placebo infusion Drug: Alfentanil
Target steady state infusion of alfentanil at a plasma concentration of 100ng/ml

  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 Angst, Professor of Anesthesia, Stanford University
ClinicalTrials.gov Identifier: NCT00672438     History of Changes
Other Study ID Numbers: SU-04212008-1119, IRB # 13018
Study First Received: May 2, 2008
Last Updated: March 23, 2012
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on November 24, 2014