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N/A Completed N=237 Randomized Double-blind

Heritability of Opioid Effects: A Twin Study

Source: ClinicalTrials.gov NCT00672438 ↗
Enrolled (actual)
237
Serious AEs
0.0%
Results posted
Jul 2016
Primary outcomePrimary: Heat Pain Threshold — 49.6; 48.6 degrees centigrade

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.

Outcome Measures

OutcomeResultp-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

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
View full record on ClinicalTrials.gov →

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. Informational only — not medical advice.

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