Phase 4
Completed N=15
Effects of Garlic Supplements on Opioids in Healthy Volunteers
Healthy, No Evidence of Disease
Source: ClinicalTrials.gov NCT00499460 ↗
Enrolled (actual)
15
Serious AEs
0.0%
Results posted
Apr 2017
Primary outcomePrimary: Oxycodone Oral Clearance — 1.82; 2.04 L/min — p=>0.05
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
Summary
RATIONALE: Garlic supplements may alter the pharmacokinetics of oxycodone, thereby affecting its effectiveness as an opioid analgesic for the relief of moderate or severe pain.
PURPOSE: This randomized phase 4 trial is studying how garlic supplements may change the pharmacokinetics of oxycodone and its analgesic and side effects in healthy volunteers.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Oxycodone Oral Clearance |
1.82; 2.04 | >0.05 |
| SECONDARY Cold Pressor Tolerance AUC |
3.513; 3.715 | >0.05 |
| SECONDARY Somatic Side Effects Total Score |
0.560; 0.711 | >0.05 |
| SECONDARY Cognitive-Affective Side Effects Total Score |
1.884; 1.714 | >0.05 |
| SECONDARY Oral Midazolam Test |
2491; 2495 | >0.05 |
| SECONDARY Oral Digoxin Test |
231; 226 | >0.05 |
Eligibility Criteria
INCLUSION CRITERIA
- Healthy volunteer
- Body mass index 20-32
EXCLUSION CRITERIA
- Not pregnant
- No history of cardiopulmonary, liver, renal, endocrine, neurologic, or psychiatric disease
- No anemia
- No known adverse reactions to opioids, benzodiazepines, cardiac glycosides, or garlic supplements
- No known allergy or hypersensitivity to sulfur-containing food or drugs
- No significant gastrointestinal intolerance to lactose in dairy products
- No recent history of alcohol or substance abuse
- No history of or concurrent heavy daily consumption of allium vegetables (i.e., garlic, shallots, leeks, and chives)
- No handicaps due to visual and hearing impairments
- No resting heart rate < 50 beats per minutes
- No abnormal cardiac rhythm by EKG
- No unusually sensitive response or resistance to pain stimulation (Cold Pressor Test)
- Must be right handed
- No color blindness
- No history of learning disabilities or dyslexia
- Must be literate and proficient in English
- Must be a nonsmoker
- No concurrent medication except oral contraceptives
- No concurrent grapefruit or grapefruit juice
- No other concurrent over-the-counter herbal products or herbal tea
Data sourced from ClinicalTrials.gov (NCT00499460). 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.