Testosterone Replacement Therapy
—by Heinz G Mayr, BSc MD
A low testosterone level is reported as a side effect in 80% of males receiving Methadone or Suboxone treatment. This article offers some guidelines for diagnosing and treating low testosterone.
Testosterone Replacement Therapy (TRT) is an essential component of the complete comprehensive care of men on Methadone (Suboxone) Maintenance Treatment (MMT).
Patients presenting symptoms including low energy, low sex drive, loss of muscle mass, osteoporosis or ennui, with a total testosterone level of less than 9 (a normal level is 8.4-29 nmol/L) and/or a free testosterone level of less than 200 (a normal level is 196-636 pmol/L) will benefit dramatically from TRT. Some chronic illnesses, like Hepatitis C, can cause an elevation of sex hormone binding globulin and present an erroneously normal total testosterone level. It is essential to determine both the free and total testosterone levels. Bioavailable testosterone level testing is not covered by the Ontario Health Insurance Plan (OHIP) [as of March 2017], and is not necessary.
The best treatment is depot intramuscular injections, every two weeks, of 200 mg of testosterone as Delatestryl, enanthate, available in 5 ml vial in sesame oil, or, Depotestosterone, cypionate, available in 10 ml vial in cottonseed oil. These five dose vials of testosterone are covered by the Ontario Disability Support Program (ODSP) and cost about $68 for five doses [as of March 2017]. While these preparations are the same drugs as those often used inappropriately by bodybuilders, the 200 mg IM every two weeks dose is a physiological dose and replaces what the body is not producing in MMT males.
Allergic reactions to depot shots are extremely rare as are side effects. Either of these preparations may cause acne in some men. This may be alleviated by switching to the other preparation. There is no conclusive evidence that TRT increases the risk of prostate cancer or cardiac disease.
These patients need the testosterone injections during the full course of MMT to get the positive metabolic effects. Taper the dose as follows: 150 mg of testosterone as the methadone dose is tapered to 15 mg/day; 100 mg of testosterone per 10 mg of methadone; and, 50 mg of testosterone per 5 mg of methadone. Only 15% of men are able to taper off MMT.
The pre-treatment workup includes a focused physical exam to rule out other illness such as breast or testicular cancer, congestive heart failure, liver failure, prostate cancer, and polycythemia with hematocrit greater than 55. Blood work would rule out prostate cancer with the PSA in men over 40 years of age. Other tests are:
- TSH, Hep C, HIV, CBC, and LFT to rule out other causes of fatigue.
- Serum ferritin level to rule out hemochromatosis.
- FSH, LH, Prolactin to rule out primary hypogonadism.
Most men in the MMT program will have secondary hypogonadism with low to normal FSH, LH, and Prolactin as a result of the effect of opiates on the hypothalamic-pituitary-testicular axis with resulting low testosterone and low sperm count. Blood work should be repeated yearly and their PSA level must be monitored to watch for prostate cancer. A PSA level greater than 4 ngm/ml, or an increase in the velocity of greater than 1.4 ngm/ml per year requires a urological referral. Most of these men refuse the rectal exam, especially if informed that it is not that reliable in detecting prostate cancer.
Many men on MMT, but not on TRT, continue to use stimulants (uppers) such as Ritalin, Cocaine, or Methamphetamine to treat symptoms of low testosterone. They would benefit more from TRT. It is essential to screen each and every one of your male MMT patients.
After about three months of regular depot IM shots every two weeks, repeating the blood test for testosterone level 7 days after the last shot should give a level of about 25 for total testosterone and 500 for free testosterone. Some men need to have the dosage increased to 250 mg every two weeks if levels are not in the therapeutic range. A Haematocrit greater than 55 would necessitate a dose decrease.
Blood tests on these men can be done any time of day rather than insisting on a morning sample. This can result in better compliance in this challenging population.
Testosterone vials should not be released by the pharmacy directly to the patient due to the high likelihood of diversion. The vials should be directly delivered to the physician’s office. They can be stored alphabetically in egg cartons on a shelf in a locked room for safety. They do not need to be refrigerated. The manufacturer states that the multi-dose vials have an expiry date of at least two years and can be used repeatedly unless they go cloudy.
Testosterone gels and tablets are prone to misuse. Depot IM injections in physician’s office avoid that risk.
If you are, or plan to be, the TRT physician in your area then it is best to have flexible TRT clinic hours, including one evening a week and Saturday mornings, as many of these men return to work as a result of the therapy. It is helpful to hand out a photocopied calendar sheet with the patient’s next appointment clearly indicated to remind them as every two week appointments may be hard to remember for some. It is possible to administer TRT as part of the regular methadone visit and bill G372 [as of March 2017]. It is also possible to setup a separate TRT-only clinic and have patients see a methadone physician and a testosterone physician on the same day, with separate billing.
We use sterile, single-use, 20 gauge, 25 mm needles with Luer lock and usually do the depot injection into the buttock, drawing back before injection to make sure we are not injecting into a vein. We have the patient rub the site for 20 seconds once we withdraw the needle to prevent bleeding or leakage. Infections or hematomas with this method are extremely rare.
The half-life of Delatestryl is 8 ½ days, and Depotestosterone is about 7 days. Some men notice they are symptomatic by Day 10-14. Some men prefer to get a half dose (100 mg) every week when they are in for their methadone visit, as it gives better symptomatic control.
Infertility with low sperm counts may occur due to MMT or opiate usage. This is due to low FSH resulting in low Sertoli cell functioning and low spermatogenesis. These testosterone shots do not improve low sperm count. TRT is just replacing the testosterone that is not made by the patient due to decreased LH stimulation of Leydig cells. Infertility and normal testosterone production may improve if the patient eventually gets off the MMT program and opiates.
It can take about three months, or six or seven shots, to get the full metabolic changes resulting in muscle weight gain of 15 pounds, fat loss, increased sex-drive, and improved mood and ambition.
Informative scientific articles that you can access online and read to get an in-depth summary of this issue are:
- Hassan J, Barkin J. Testosterone deficiency syndrome: benefits, risks, and realities associated with testosterone replacement therapy. The Canadian Journal of Urology. 2016; 23 (11): 20-30.
- Morales A, Bebb R, Manjoo P, et al. Diagnosis and management of testosterone deficiency syndrome in men: clinical practice guideline. Canadian Medical Association Journal. 2015; 187 (18): 1369-1377.
About the author: Heinz Mayr, BSc, MD earned his BSc. from the McGill University (1970) and his medical degree at the University of Western Ontario (1975). He lives in London, Ontario and maintained a general practice there from 1975 to 2007. He has practiced in the area of MMT and TRT since 2007. His article outlines a protocol developed by Dr. Mayr in over five years of treating these men at Clinic 528 in London, Ontario and reviewing the relevant literature.
Colleagues can contact Dr. Mayr with any questions and may arrange to audit one of his Saturday morning clinics (please contact him for details).
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