PainNCT01220414
Attenuation of Pain in Men and Women
A study of Pain, run by University of Wisconsin, Madison at 1 site in United States.
Trial summary
The purpose of this study is to examine opioid and endocannabinoid mechanisms of exercise-induced analgesia in men and women. Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Pain
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2010to Jan 2013
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- -
Who cannot join
- current cardiac or other chronic diseases (e.g., cancer, diabetes, hypertension, kidney disease); routine use of prescriptive medications; history of vasovagal response to phlebotomy; an allergy to naltrexone; pregnancy; current smokers; current use of recreational drugs; history of substance abuse
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Wisconsin-Madison
Madison, Wisconsin, 52706
About this study
Official title: Attenuation of Pain in Men and Women: Mechanisms of Exercise-Induced Analgesia
The purpose of this study is to examine opioid and endocannabinoid mechanisms of exercise-induced analgesia in men and women.
- Conditions
- Pain
- Being tested
- Naltrexone, then placebo, Placebo, then Naltrexone
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Naltrexone, then placeboDrug
50 mg of naltrexone
Placebo, then NaltrexoneDrug
sugar pill
| Study group | Role | What they receive |
|---|---|---|
| Men | Active comparator | Not described Receives: Drug: Naltrexone, then placebo; Drug: Placebo, then Naltrexone |
| Women | Active comparator | Not described Receives: Drug: Naltrexone, then placebo; Drug: Placebo, then Naltrexone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time for Subject to Reach Pain Threshold
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Oct 2010 (estimated)
- Study startSep 2010
- Primary completionJan 2013
- Study completionJan 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for PainStudies of the same condition, open and under way.
- More trials run by University of Wisconsin, MadisonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Wisconsin, Madison
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01220414
- Sponsor's protocol ID
- H-2010-0087
- Status last verified
- Jan 2018
- First submitted
- 28 Sep 2010
- Last updated
- 19 Feb 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 19 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Attenuation of Pain in Men and Women: Mechanisms of Exercise-Induced Analgesia
- ClinicalTrials.gov ID
- NCT01220414
- Acronym / sponsor ID
- H-2010-0087
- Conditions
- Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- University of Wisconsin, MadisonUniversity, hospital or other
- Study start
- Sep 2010
- Primary completion
- Jan 2013 (actual)
- Study completion
- Jan 2013 (actual)
- First posted
- 13 Oct 2010 (estimated)
- Results
- Posted 19 Feb 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to examine opioid and endocannabinoid mechanisms of exercise-induced analgesia in men and women.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Men | Active comparator | Drug: Naltrexone, then placebo, Drug: Placebo, then Naltrexone |
| Women | Active comparator | Drug: Naltrexone, then placebo, Drug: Placebo, then Naltrexone |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- -
Key exclusion criteria (1 listed)
- current cardiac or other chronic diseases (e.g., cancer, diabetes, hypertension, kidney disease); routine use of prescriptive medications; history of vasovagal response to phlebotomy; an allergy to naltrexone; pregnancy; current smokers; current use of recreational drugs; history of substance abuse
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Naltrexone, then placebo50 mg of naltrexone | Drug | Men, Women |
| Placebo, then Naltrexonesugar pill | Drug | Men, Women |
Primary outcome
Time for Subject to Reach Pain Threshold
Time frame: Baseline
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Feb 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study of Pain, run by University of Wisconsin, Madison at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Feb 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 19 Feb 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time for Subject to Reach Pain Threshold (time frame: Baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Feb 2018.