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PainPhase 2NCT00398034

Analgesic Efficacy of Testosterone Replacement in Hypogonadal Opioid-treated Chronic Pain Patients: A Pilot Study.

A Phase 2 study testing Testosterone Gel in people with Pain and Hypogonadism, run by James J. Peters Veterans Affairs Medical Center.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial summary

The purpose of this pilot study is to test the effects of testosterone replacement on pain, fatigue, mood, cognition and libido in hypogonadal men on long-term opioid therapy for chronic pain. Read more about this study

Who is it for?
Ages 18 to 60 years, men only
Conditions the study is for
Pain, Hypogonadism
What is being tested?
Testosterone Gel
How many people
0 participants
Where
No sites listed yet
Study dates
30 Oct 2006to 6 Sep 2007
Phase
Phase 2
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 60 years
  • Men only
  • No healthy volunteers
  • Adult

Who may be able to join

  • Adult male patients (above 18 years old and below 60 years old)
  • Receiving greater than 20 IV morphine equivalents/day with <20% change in dosage in the last month.
  • AM total testosterone <300 ng/dL
  • Report "worst pain during the past week" grater than 4 on an 11-point numeric scale.

Who cannot join

  • Females
  • Poorly controlled, symptomatic, active medical or psychiatric problems (e.g., HIV, hepatitis, diabetes, cancer, benign prostatic hypertrophy, substance abuse, major depression)
  • Neurological or psychiatric disorder that would compromise the patient's ability to give informed consent or adhere to the requirements of the protocol.
  • History of prostate cancer, abnormal findings on digital rectal exam, or PSA greater than 4.0 ng/m
  • History of polycythemia
  • Renal or hepatic dysfunction
Show all 9Show fewer
  • Hematocrit >55%
  • Known history of hypersensitivity to transdermal testosterone gel.
  • Abnormalities during digital rectal exam.

About this study

The purpose of this pilot study is to test the effects of testosterone replacement on pain, fatigue, mood, cognition and libido in hypogonadal men on long-term opioid therapy for chronic pain.

Read the detailed description

Opioids are increasingly used for the treatment of non-malignant chronic pain with as many as five to ten million patients treated at the time of the most recent estimate in 2002. The side effects of opioids such as fatigue, loss of libido, Impaired cognition and sexual dysfunction have long been recognize and strikingly, resemble symptoms of hypogonadism in men. Many studies have demonstrated a high prevalence of hypogonadism in male subjects who are long-term users of opioids. The aims of this pilot study are, in hypogonadal men being treated with opioids for chronic pain, to: 1) determine the effect of TRT on pain; 2) determine effects of TRT on fatigue; 3) determine the effect of TRT on mood; 4) determine effects of TRT on cognition and 5) characterize the effects of TRT on sexual dysfunction. This study is a randomized, placebo-controlled, 6-week pilot study.

Conditions
Pain, Hypogonadism
Being tested
Testosterone Gel
Keywords
opioids, pain, hypogonadism, depression, fatigue, cognition, libido
Medical subject headings
Pain, Hypogonadism, Depression, Fatigue

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Testosterone GelDrug

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. • To determine if testosterone replacement can improve pain control in opioid-treated, hypogonadal men with chronic pain.

Secondary outcomes (7)

  1. In opioid-treated, hypogonadal men with chronic pain, to determine whether testosterone replacement therapy (TRT) will:

  2. reduce the opioid requirement.

  3. improve fatigue

  4. improve depression

  5. improve sexual function.

  6. Improve cognition

  7. To determine the proportion of responders to the analgesic effects of TRT

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Nov 2006 (estimated)
  2. Study start30 Oct 2006
  3. Primary completion6 Sep 2007
  4. Study completion6 Sep 2007

Why it stopped: The original PI (David Siegel) Left the VA

Resources

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 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00398034
Sponsor's protocol ID
2192-06-049
Status last verified
Nov 2006
First submitted
8 Nov 2006
Last updated
13 Oct 2023
Results posted
No

Publications

  • American Pain Society, Guidelines for the Management of Acute and Cancer Pain. 4 ed. 1999, Glenview, IL: American Pain Society.

  • Portenoy RK. Opioid therapy for chronic nonmalignant pain: a review of the critical issues. J Pain Symptom Manage. 1996 Apr;11(4):203-17. doi: 10.1016/0885-3924(95)00187-5.

    PubMed 8869456

  • Rigoni, G. Drug Utilization for Immediate- and Modified Release Opioids in the U.S. in FDA Anesthesia, Life Support, and Addiction Drug Products Advisory Committee. 2003. Gaithersburg, Maryland.

  • Bair MJ, Robinson RL, Katon W, Kroenke K. Depression and pain comorbidity: a literature review. Arch Intern Med. 2003 Nov 10;163(20):2433-45. doi: 10.1001/archinte.163.20.2433.

    PubMed 14609780

  • Passchier J, Rupreht J, Koenders ME, Olree M, Luitwieler RL, Bonke B. Patient-controlled analgesia (PCA) leads to more postoperative pain relief, but also to more fatigue and less vigour. Acta Anaesthesiol Scand. 1993 Oct;37(7):659-63. doi: 10.1111/j.1399-6576.1993.tb03784.x.

    PubMed 8249554

  • Jarvik LF, Simpson JH, Guthrie D, Liston EH. Morphine, experimental pain, and psychological reactions. Psychopharmacology (Berl). 1981;75(2):124-31. doi: 10.1007/BF00432173.

    PubMed 6798601

  • Cicero TJ, Bell RD, Wiest WG, Allison JH, Polakoski K, Robins E. Function of the male sex organs in heroin and methadone users. N Engl J Med. 1975 Apr 24;292(17):882-7. doi: 10.1056/NEJM197504242921703.

    PubMed 1117911

  • Crowley TJ, Simpson R. Methadone dose and human sexual behavior. Int J Addict. 1978 Feb;13(2):285-95. doi: 10.3109/10826087809039281.

    PubMed 640760

  • Cushman P Jr. Sexual behavior in heroin addiction and methadone maintenance. Correlation with plasma luteinizing hormone. N Y State J Med. 1972 Jun 1;72(11):1261-5. No abstract available.

    PubMed 4503902

  • Mintz J, O'Hare K, O'Brien CP, Goldschmidt J. Sexual problems of heroin addicts. Arch Gen Psychiatry. 1974 Nov;31(5):700-3. doi: 10.1001/archpsyc.1974.01760170088014. No abstract available.

    PubMed 4474860

  • Smith DE, Moser C, Wesson DR, Apter M, Buxton ME, Davison JV, Orgel M, Buffum J. A clinical guide to the diagnosis and treatment of heroin-related sexual dysfunction. J Psychoactive Drugs. 1982 Jan-Jun;14(1-2):91-9. doi: 10.1080/02791072.1982.10471916.

    PubMed 7119946

  • Azizi F, Vagenakis AG, Longcope C, Ingbar SH, Braverman LE. Decreased serum testosterone concentration in male heroin and methadone addicts. Steroids. 1973 Oct;22(4):467-72. doi: 10.1016/0039-128x(73)90002-0. No abstract available.

    PubMed 4747447

  • Bolelli G, Lafisca S, Flamigni C, Lodi S, Franceschetti F, Filicori M, Mosca R. Heroin addiction: relationship between the plasma levels of testosterone, dihydrotestosterone, androstenedione, LH, FSH, and the plasma concentration of heroin. Toxicology. 1979 Dec;15(1):19-29. doi: 10.1016/0300-483x(79)90016-7.

    PubMed 120622

  • Cushman P Jr. Plasma testosterone in narcotic addiction. Am J Med. 1973 Oct;55(3):452-8. doi: 10.1016/0002-9343(73)90202-7. No abstract available.

    PubMed 4743346

  • Mendelson JH, Mendelson JE, Patch VD. Plasma testosterone levels in heroin addiction and during methadone maintenance. J Pharmacol Exp Ther. 1975 Jan;192(1):211-17.

    PubMed 1123724

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Testosterone Gel in people with Pain and Hypogonadism, run by James J. Peters Veterans Affairs Medical Center.

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 4 inclusion and 9 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: withdrawn, as of the sponsor's last update on 13 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.

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.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was withdrawn before enrolling participants, so there are no results.

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?

• To determine if testosterone replacement can improve pain control in opioid-treated, hypogonadal men with chronic pain.. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00398034, which also lists 70 linked publications.

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 13 Oct 2023.

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