Opiate DependenceNCT00170339
Bone Density and Serum Testosterone in Male Methadone Maintained Patients
An observational study of Opiate Dependence and Osteoporosis, run by Hennepin Healthcare Research Institute at 1 site in United States.
Trial summary
This is a pilot study designed to answer the question " Do men who are receiving methadone maintenance therapy have lower spinal bone densities compared with age-matched controls who are not receiving methadone therapy?" The primary aim is to assess whether the mean or median spinal dual-ray energy x-ray… Read more about this study
- Who is it for?
- Ages 18 to 50 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Opiate Dependence, Osteoporosis, Erectile Dysfunction
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2005to Apr 2007
- Phase
- Observational
- Are there results?
- None posted in the registry
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 50 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- age 18 to 50
- methadone maintenance for at least 12 months (for cases)
- stable dose of methadone for 6 months (for cases)
- willing to participate in the study
- competency in English
- male
Who cannot join
- previous diagnosis of sexual dysfunction
- previous diagnosis of osteoporosis
- serum creatinine > 2 mg/dL
- chronic opiate use (for controls)
- congestive heart failure
- illicit drug use
Trial locations and contacts
1 site in 1 country.
United States1 site
Hennepin Faculty Associates/ Hennepin County Medical Center
Minneapolis, Minnesota, 55415
About this study
This is a pilot study designed to answer the question " Do men who are receiving methadone maintenance therapy have lower spinal bone densities compared with age-matched controls who are not receiving methadone therapy?"
The primary aim is to assess whether the mean or median spinal dual-ray energy x-ray absorptiometry (DEXA) scan results are different between these two groups of male patients. Primary measurements include: spinal bone densitometry by DEXA scan.
The secondary aim is to examine the role of sex steroids in men receiving methadone maintenance therapy and their association with spinal bone density and sexual dysfunction. Secondary measurements include: serum testosterone, estradiol, lutenizing hormone, albumin, sex hormone binding globulin and Vitamin D levels; age; Brief Sexual Function Inventory; Dietary, smoking/alcohol use and physical activity; Medical history, surgical and medication use; length of time using illicit opiates and time on methadone maintenance therapy.
Read the detailed description
Chronic use of opiates has long been associated with multiple side effects, many of which are due to lower levels of androgens in this patient population. Previous studies have shown that long-term opiate use may lead to narcotic induced hypogonadism, resulting in significantly decreased testosterone levels in men. One area of chronic opiate use that has not been looked at extensively is the correlation between narcotic-induced hypogonadism and associated side effects such as osteoporosis and sexual dysfunction in male patients receiving methadone maintenance therapy. Marked testosterone deficiency is a well-established rick factor for both osteoporosis and altered sexual function, and recent information demonstrated that altered estrogen levels may play a role in these side effects as well. Thre present pilot study investigates the role of sex steroids in male patients maintained on methadone therapy and their association with bone densitometry and sexual dysfunction. Free testosterone, estradiol, lutenizing hormone, sex hormone binding globulin, Vitamin D levels and albumin will be measured in thirty community-dwelling outpatient men participating in a methadone maintenance program as well as thirty age-matched controls from a general medicine clinic. Osteodensitometry will be performed with the DEXA technique at the lumbar spine. Participants will also complete the Brief Male Sexual Function Inventory as well as be assessed for smoking/alcohol use, calcium intake, physical activity, length of time receiving opiates as well as concurrent medications. It is hypothesized that patients receiving methadone maintenance therapy will have lower bone mass densities, free testosterone, estradiol, and sexual dysfunction scores than the age-matched controls.
- Conditions
- Opiate Dependence, Osteoporosis, Erectile Dysfunction, Hypogonadism
- Keywords
- Opiate Dependence, Methadone Maintenance, Osteoporosis, Hypogonadism
- Medical subject headings
- Opioid-Related Disorders, Osteoporosis, Erectile Dysfunction, Hypogonadism
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2005 (estimated)
- Study startApr 2005
- Study completionApr 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Opiate DependenceStudies of the same condition, open and under way.
- 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
- Observational
- Time perspective
- Prospective
- Enrolment
- 60 participants
Sponsor and investigators
- Lead sponsor
- Hennepin Healthcare Research Institute
- Sponsor type
- University, hospital or other
- Investigators
- Kathleen M Wesa, M.D., Principal investigator, Hennepin Faculty Associates/ Hennepin County Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00170339
- Sponsor's protocol ID
- HSR-04-2404
- Other IDs
- 0409M63575
- Status last verified
- Sep 2016
- First submitted
- 9 Sep 2005
- Last updated
- 14 Sep 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bone Density and Serum Testosterone in Male Methadone Maintained Patients
- ClinicalTrials.gov ID
- NCT00170339
- Acronym / sponsor ID
- HSR-04-2404
- Conditions
- Opiate Dependence, Osteoporosis, Erectile Dysfunction, Hypogonadism
- Keywords
- Opiate Dependence, Methadone Maintenance, Osteoporosis, Hypogonadism
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants
- Lead sponsor
- Hennepin Healthcare Research InstituteUniversity, hospital or other
- Study start
- Apr 2005
- Study completion
- Apr 2007 (actual)
- First posted
- 15 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a pilot study designed to answer the question " Do men who are receiving methadone maintenance therapy have lower spinal bone densities compared with age-matched controls who are not receiving methadone therapy?"
The primary aim is to assess whether the mean or median spinal dual-ray energy x-ray absorptiometry (DEXA) scan results are different between these two groups of male patients. Primary measurements include: spinal bone densitometry by DEXA scan.
The secondary aim is to examine the role of sex steroids in men receiving methadone maintenance therapy and their association with spinal bone density and sexual dysfunction. Secondary measurements include: serum testosterone, estradiol, lutenizing hormone, albumin, sex hormone binding globulin and Vitamin D levels; age; Brief Sexual Function Inventory; Dietary, smoking/alcohol use and physical activity; Medical history, surgical and medication use; length of time using illicit opiates and time on methadone maintenance therapy.
Detailed description
Chronic use of opiates has long been associated with multiple side effects, many of which are due to lower levels of androgens in this patient population. Previous studies have shown that long-term opiate use may lead to narcotic induced hypogonadism, resulting in significantly decreased testosterone levels in men. One area of chronic opiate use that has not been looked at extensively is the correlation between narcotic-induced hypogonadism and associated side effects such as osteoporosis and sexual dysfunction in male patients receiving methadone maintenance therapy. Marked testosterone deficiency is a well-established rick factor for both osteoporosis and altered sexual function, and recent information demonstrated that altered estrogen levels may play a role in these side effects as well. Thre present pilot study investigates the role of sex steroids in male patients maintained on methadone therapy and their association with bone densitometry and sexual dysfunction. Free testosterone, estradiol, lutenizing hormone, sex hormone binding globulin, Vitamin D levels and albumin will be measured in thirty community-dwelling outpatient men participating in a methadone maintenance program as well as thirty age-matched controls from a general medicine clinic. Osteodensitometry will be performed with the DEXA technique at the lumbar spine. Participants will also complete the Brief Male Sexual Function Inventory as well as be assessed for smoking/alcohol use, calcium intake, physical activity, length of time receiving opiates as well as concurrent medications. It is hypothesized that patients receiving methadone maintenance therapy will have lower bone mass densities, free testosterone, estradiol, and sexual dysfunction scores than the age-matched controls.
Study design
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- age 18 to 50
- methadone maintenance for at least 12 months (for cases)
- stable dose of methadone for 6 months (for cases)
- willing to participate in the study
- competency in English
Key exclusion criteria (6 listed)
- previous diagnosis of sexual dysfunction
- previous diagnosis of osteoporosis
- serum creatinine > 2 mg/dL
- chronic opiate use (for controls)
- congestive heart failure
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Sep 2016.
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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.
Kathleen M Wesa, M.D. principal investigator
Hennepin Faculty Associates/ Hennepin County Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Opiate Dependence and Osteoporosis, run by Hennepin Healthcare Research Institute 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 6 inclusion and 6 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 14 Sep 2016. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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.
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 14 Sep 2016.