Effects of Testosterone Replacement on Pain Sensitivity and Pain Perception (TAP)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Shehzad Basaria, Brigham and Women's Hospital
ClinicalTrials.gov Identifier:
NCT00351819
First received: July 12, 2006
Last updated: July 18, 2014
Last verified: July 2014
  Purpose

Naturally occurring opiates (endorphins) decrease testosterone levels by inhibiting the synthesis of gonadotropin releasing hormone (GnRH) and also inhibiting testosterone synthesis by the testes. Similarly, men with addiction to narcotics and those on exogenous opioids for pain control have decreased serum testosterone levels. Indeed, these men complain of decreased libido, erectile dysfunction and impaired quality of life. Animal studies have shown that gonadectomy results in a decrease in pain threshold in rats and repletion of testosterone elevates that threshold. These observations suggest that testosterone may possess analgesic properties. Hence, the investigators hypothesize that hypogonadism developing in men on opioids results in an increased sensitivity to pain and requirement of higher doses of opioids. In this study, the investigators plan to administer testosterone to men with opioid-induced hypogonadism and evaluate their pain perception, pain sensitivity in response to noxious stimuli and changes in the requirement of opioids in response to testosterone administration.

Hypothesis:

Testosterone replacement in men with opioid-induced hypogonadism will improve pain tolerance, pain perception and quality of life.

Specific aims:

  1. To evaluate the effects of testosterone replacement on pain sensitivity, pain tolerance, and pain modulation in men with opioid-induced hypogonadism.
  2. To determine the effects of testosterone replacement on health-related quality of life.
  3. To determine whether testosterone replacement in hypogonadal men induces changes in the dosage requirements of opioid medications for pain control.

To accomplish our specific aims, the investigators propose a randomized, double blind, placebo-controlled, parallel arm study in which hypogonadal men with non-cancer chronic back pain syndrome on chronic opioids and low testosterone levels (<300 ng/dl) will be randomized to exogenous testosterone replacement therapy vs placebo. Our primary outcome is change in pain tolerance using various external painful stimuli. Secondary outcomes are change in pain sensitivity and modulation, quality of life and opioid requirements.


Condition Intervention
Pain
Hypogonadism
Drug: Androgel (testosterone gel)
Other: Placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Effects of Testosterone Replacement on Pain Sensitivity and Pain Perception in Men With Chronic Pain Syndrome

Resource links provided by NLM:


Further study details as provided by Boston University:

Primary Outcome Measures:
  • To evaluate the changes in pain tolerance in men with opioid-induced hypogonadism in response to testosterone replacement. [ Time Frame: 14-weeks after beginning study medication ] [ Designated as safety issue: No ]

Enrollment: 84
Study Start Date: April 2006
Study Completion Date: November 2012
Primary Completion Date: November 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Androgel (testosterone gel)
Testosterone replacement therapy
Drug: Androgel (testosterone gel)
5g gel, applied once daily to the upper arms, upper back or shoulders.
Placebo Comparator: Placebo
Placebo gel
Other: Placebo
5g gel, applied once daily to the upper arms, upper back or shoulders.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Men
  • Age 18 years and older
  • Non-cancer chronic pain
  • Serum total testosterone level <350 ng/dl
  • Consumption of at least 20 mg of hydrocodone (or analgesic equivalent of another opioid) for at least 4 weeks
  • Absence of hospitalization in the past 2 months
  • No acute illness in the past 2 months
  • No current anabolic therapy (growth hormone, DHEA, etc)
  • No current use or consumption in the past 2 months of melatonin
  • Normal prostate exam
  • Normal PSA level

Exclusion Criteria:

  • Cancer-related chronic pain
  • Liver enzymes > 3 times upper limit of normal
  • Serum creatinine > 2 times upper limit of normal
  • Neurological disease
  • Active psychiatric illness
  • Any addictive drug use
  • Alcoholism (>3 drinks/day)
  • Patients currently receiving melatonin or anabolic agents
  • Hospitalization in the past 2 months
  • Acute illness in the past 2 months
  • Consumption of < 20 mg of hydrocodone (or analgesic equivalent of another opioid)
  • Severe BPH
  • PSA > 4.0 ng/ml
  • Prostate cancer
  • Breast cancer
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00351819

Locations
United States, Massachusetts
Brigham and Women's Hospital
Boston, Massachusetts, United States, 02115
Sponsors and Collaborators
Boston University
Investigators
Principal Investigator: Shehzad Basaria, MD Brigham and Women's Hospital
  More Information

No publications provided

Responsible Party: Shehzad Basaria, ASSOCIATE PROFESSOR, Brigham and Women's Hospital
ClinicalTrials.gov Identifier: NCT00351819     History of Changes
Other Study ID Numbers: H-27995
Study First Received: July 12, 2006
Last Updated: July 18, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Boston University:
Testosterone
Pain
Opioid
Hypogonadism

Additional relevant MeSH terms:
Hypogonadism
Gonadal Disorders
Endocrine System Diseases
Testosterone
Testosterone enanthate
Testosterone undecanoate
Testosterone 17 beta-cypionate
Methyltestosterone
Androgens
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Therapeutic Uses
Anabolic Agents

ClinicalTrials.gov processed this record on September 16, 2014