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The purpose of this study is to examine opioid and endocannabinoid mechanisms of exercise-induced analgesia in men and women.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Men | Active Comparator |
| |
| Women | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Naltrexone, then placebo | Drug | 50 mg of naltrexone |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Time for Subject to Reach Pain Threshold | Baseline |
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Inclusion Criteria: Healthy men and women
-
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Wisconsin-Madison | Madison | Wisconsin | 52706 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Males, Naltrexone Then Placebo | |
| FG001 | Males, Placebo Then Naltrexone | |
| FG002 | Females, Naltrexone Then Placebo | |
| FG003 | Females, Placebo Then Naltrexone |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Naltrexone Then Placebo | All participants completed both naltrexone and placebo conditions |
| BG001 | Placebo Then Naltrxone | |
| BG002 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Time for Subject to Reach Pain Threshold | Posted | Mean | Standard Deviation | seconds | Baseline |
|
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Naltrexone and Placebo | Participants completed both naltrexone and placebo conditions |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Kelli F. Koltyn | University of Wisconsin-Madison | 608 262-4234 | kelli.koltyn@wisc.edu |
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| ID | Term |
|---|---|
| D010146 | Pain |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D009271 | Naltrexone |
| ID | Term |
|---|---|
| D009270 | Naloxone |
| D009019 | Morphinans |
| D053610 | Opiate Alkaloids |
| D000470 | Alkaloids |
| D006571 |
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| Placebo, then Naltrexone |
| Drug |
sugar pill |
|
| Total |
Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Counts |
|---|
| Participants |
|
|
| 0 |
| 60 |
| 0 |
| 60 |
| 0 |
| 60 |
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| Heterocyclic Compounds |
| D006572 | Heterocyclic Compounds, Bridged-Ring |
| D006576 | Heterocyclic Compounds, 4 or More Rings |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D010616 | Phenanthrenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D011083 | Polycyclic Compounds |