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| Tracking Information | |||||||||
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| First Received Date ICMJE | May 2, 2008 | ||||||||
| Last Updated Date | February 12, 2009 | ||||||||
| Start Date ICMJE | May 2008 | ||||||||
| Estimated Primary Completion Date | June 2011 (final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE |
To what degree are inter-individual differences in pain sensitivity and pain relief in response to opioid therapy inherited. | ||||||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||||||
| Change History | Complete list of historical versions of study NCT00672438 on ClinicalTrials.gov Archive Site | ||||||||
| Current Secondary Outcome Measures ICMJE |
To what degree are inter-individual differences in other effects of opioid medications inherited. | ||||||||
| Original Secondary Outcome Measures ICMJE | Same as current | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Heritability of Opioid Effects: A Twin Study | ||||||||
| Official Title ICMJE | Heritability of Opioid Effects: A Twin Study | ||||||||
| Brief Summary | 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. |
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| Detailed Description | |||||||||
| Study Phase | |||||||||
| Study Type ICMJE | Interventional | ||||||||
| Study Design ICMJE | Other, Randomized, Double-Blind, Placebo Control, Crossover Assignment, Pharmacokinetics/Dynamics Study | ||||||||
| Condition ICMJE | Pain | ||||||||
| Intervention ICMJE | Drug: Alfentanil | ||||||||
| Study Arms / Comparison Groups | |||||||||
| Publications * | |||||||||
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Recruiting | ||||||||
| Estimated Enrollment ICMJE | 250 | ||||||||
| Completion Date | |||||||||
| Estimated Primary Completion Date | June 2011 (final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE | 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 |
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| Gender | Both | ||||||||
| Ages | 18 Years to 70 Years | ||||||||
| Accepts Healthy Volunteers | Yes | ||||||||
| Contacts ICMJE |
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| Location Countries ICMJE | United States | ||||||||
| Administrative Information | |||||||||
| NCT ID ICMJE | NCT00672438 | ||||||||
| Responsible Party | Nick Phillips, BS, BA, MTOM | ||||||||
| Study ID Numbers ICMJE | SU-04212008-1119, IRB # 13018 | ||||||||
| Study Sponsor ICMJE | Stanford University | ||||||||
| Collaborators ICMJE | SRI | ||||||||
| Investigators ICMJE |
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| Information Provided By | Stanford University | ||||||||
| Verification Date | February 2009 | ||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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