Symptoms and General Pathology

All Conditions

Nervous System Diseases

Rare Diseases

Chronic Pain

Pain

Neurologic Manifestations

Chronic Graft Versus Host Disease

Analgesics

Central Nervous System Depressants

All Drugs and Chemicals

Morphine

Analgesics, Opioid

Narcotics

Subjects who are on a stable dose of daily opioid therapy for at least 6 months will have their opioid medication doses slowly and gradually reduced every 4 weeks.

Subjects who are on a stable dose of daily opioid therapy for at least 6 months will stay on the same dose of opioids they are currently using at the beginning of the study for the entire 12-month duration of the study.

Clinically prescribed daily opioids reduced by no more than 10 morphine milligram equivalent per day (MMED) each month for 12 months

Slow Tapering of Chronic Opioid Therapy

Terrence Witt, MD

The purpose of this study is to find out if patients who have been taking a stable dose of opioids for chronic pain would experience any worsening pain, quality of life and functioning, as well as symptoms of depression and anxiety if their opioid medications are gradually and very slowly reduced.

Slow Opioid Tapering Pilot Study of Patients Using Chronic Opioid Therapy

A Pilot Study of Slow Opioid Tapering Compared to Continued Opioid Therapy in Treating Chronic Non-Cancer Pain

Measured by the Medical Outcomes Study Questionnaire Short Form Health 36 Survey (SF36v2).The SF-36 is a multi-purpose self-reported survey designed to capture adult patients' perceptions of their own health and well-being.

Measured using the Physical Health Questionnaire-9 (PHQ-9). The PHQ-9 is a 9-item self-assessment survey which is a reliable and valid measure of depression severity used in both the clinical and research field. Total scores on a scale of 1-27 with higher score indicated higher depression severity.

Measured using the Generalized Anxiety Disorder Questionnaire-7 (GAD-7). The GAD-7 is a valid and efficient tool for screening for generalized anxiety disorder and assessing its severity in clinical practice and research. Patients indicate one of the 4 numbers (representing severity) associated with 7 problems. Total score symptom range 0-21 with higher score indicated higher anxiety severity.

Mayo Clinic

Principal Investigator

Neoplasms

Gland and Hormone Related Diseases

Neoplasm Metastasis

Syndrome

Cancer Pain

Hypogonadism

Gonadal Disorders

Endocrine System Diseases

Testosterone

Males on chronic opioid therapy for cancer-related pain syndromes

A set of questionnaires regarding sexual function, physical and psychological symptoms.

Questionnaire

Testosterone, FSH, and LH levels at study onset.

Blood draws to assess gonadal function

Arun Rajagopal, MD

Primary Objective:

1. To determine the prevalence of secondary hypogonadism in male patients on chronic opioid therapy for cancer-related pain syndromes.

Secondary Objective:

1. To determine the degree of sexual dysfunction, fatigue, and depression prevalent in male patients on chronic opioid therapy for cancer-related pain syndromes.

Studies have shown that non-cancer patients taking opioid pain medication for a long period of time can have decreased libido and decreased sexual function.

Individuals may be asked to take part in this study even if they have not taken opioid pain medications in the last twelve months. These individuals would also be enrolled to learn if long-term treatment of cancer-related pain with opioid medications results in decreased sex hormones, decreased sex drive, and increased fatigue or depression.

Participants in this study will be asked to complete a set of questions about their sexual functions, physical symptoms, and psychological symptoms such as fatigue and depression. It will take about 25 minutes to complete the questionnaires.

Participants will have blood drawn (about 2 teaspoons of blood) to test their sex hormone level. Participants who are identified as having low sex hormone level (hypogonadism) will be referred to an endocrinologist for standard hormone replacement therapy.

This is a one-time evaluation, no follow-up visit or questionnaires are required.

This is an investigational study. A total of 108 individuals will take part in this study. All will be enrolled at UTMDACC.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Slow Opioid Tapering Pilot Study of Patients Using Chronic Opioid Therapy	NCT05297396	Chronic Pain Opioid Use	Slow Tapering o...	18 Years -	Mayo Clinic
Prevalence of Secondary Hypogonadism in Male Patients on Chronic Opioid Therapy for Cancer-Related Pain Syndromes	NCT00529230	Advanced Cancer Hypogonadism Pain	Questionnaire Blood draws to ...	18 Years -	M.D. Anderson Cancer Center
Slow Opioid Tapering Pilot Study of Patients Using Chronic Opioid Therapy	NCT05297396	Chronic Pain Opioid Use	Slow Tapering o...	18 Years -	Mayo Clinic

Spots Global Cancer Trial Database for chronic opioid therapy