N/A
N=237
Heritability of Opioid Effects: A Twin Study
Pain
Bottom Line
View on ClinicalTrials.gov: NCT00672438 ↗Enrolled (actual)
237
Serious AEs
0.0%
Results posted
Jul 2016
Primary outcome: Primary: Heat Pain Threshold — 49.6; 48.6 degrees centigrade
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Alfentanil (Drug); Saline placebo infusion (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Martin Angst
- Primary completion
- Jun 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Heat Pain Threshold |
49.6; 48.6 | — |
| PRIMARY Cold Pain Threshold |
15; 8 | — |
| PRIMARY Cold Pain Tolerance |
32; 17 | — |
| PRIMARY Respiratory Rate |
11; 14 | — |
| PRIMARY Transcutaneous Partial Pressure of Carbon Dioxide |
47.7; 40.3 | — |
| SECONDARY Sedation |
70; 63 | — |
| SECONDARY Average Nausea |
1; 0 | — |
| SECONDARY Maximum Nausea |
8; 0 | — |
| SECONDARY Average Pruritis |
20; 0 | — |
| SECONDARY Maximum Pruritis |
35; 0 | — |
| SECONDARY Average Drug Liking |
50; 0 | — |
| SECONDARY Maximum Drug Liking |
75; 0 | — |
| SECONDARY Maximum Drug Disliking |
23; 0 | — |
| SECONDARY Sedation by Patient Report |
75; 0 | — |
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.
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT00672438). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.