Analgesic Tolerance to Repeated Doses of Subcutaneous Morphine

NCT00256347 | Completed

• 1 other identifier: H5612-25135
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

30 healthy volunteers will be enrolled in this 6-session study. The first visit will be a screening/orientation session. The next 5 visits will be (full day) outpatient sessions taking place Monday through Friday during one week. All full day visits will be drug administration sessions with subjects randomized to one of two groups. The primary purpose is to investigate the time course of development of analgesic tolerance (loss of pain relieving effect) to morphine on experimentally produced skin tenderness in healthy volunteers.

Conditions

Healthy Volunteers

Outcome Measures

Primary Outcomes (1)

• To investigate the time course of development of analgesic tolerance (loss of pain relieving effect) to morphine on experimentally produced skin tenderness in healthy volunteers.

Secondary Outcomes (1)

• To expand the knowledge about the analgesic (pain relieving) effects of opioids on experimentally induced pain and further validate the Brief Thermal Sensitization model as a tool for testing analgesic drugs.

Interventions

intramuscular injections of morphine DRUG

Eligibility Criteria

• Age: 21 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy volunteers who are 21-50 years of age,
• If female, must be non-lactating, not pregnant, and using a reliable contraception method (i.e. abstinence, intrauterine device \[IUD\], hormonal birth control, or double barrier method \[male condom, female condom, or diaphragm plus a spermicidal agent such as contraceptive foam, jelly or cream\]).
• In stable health
• Must weigh between 110 and 200 lbs and have a Body Mass Index between 20 and 30.
• Able and willing to provide written informed consent
• Able to understand and follow the instructions of the investigator, including the pain intensity rating scales
• Develops temporary secondary hyperalgesia from the brief thermal sensitization stimulation procedure performed at the screening visit (Session 1)
• Opioid naïve (no previous history of long term opioid use)

You may not qualify if:

• Severe coronary artery disease, uncontrolled hypertension, cardiac ventricular conduction abnormalities, or orthostatic mean blood pressure drop \> than 25 mmHg, severe chronic obstructive pulmonary disease.
• History of renal or hepatic failure.
• Evidence of hepatic, hematological, or renal dysfunction based on judgment of physician.
• Subjects receiving treatment with topical steroids in areas to be stimulated.
• Dermatopathology, skin hypersensitivity, or skin lesions in the area of measurements on the thigh and forearm.
• Allergy to opioids.
• Concomitant treatment with anticonvulsants, antidepressants, NMDA blockers, muscle relaxants, sedatives, other psychotropic drugs or opioids.
• Is currently taking or has taken a monamine oxidase inhibitor (MAOI) drug within two weeks prior to study medication sessions.
• Use of NSAIDs or acetaminophen within 36 hours of drug treatment sessions and/or use of caffeine or alcohol beginning 24 hours prior to the first drug treatment sessions.
• Use of long-acting NSAIDs such as piroxicam or naproxen (Naprosyn) within 1 week of oral drug treatment sessions.
• Heat pain detection thresholds above 47°C/116.6°F on the arm (see below).
• Subjects who are not within following parameters for weight: between 110 and 200 pounds and between 20 and 30 using the Body Mass Index.
• Subjects who are unable to read or speak English.
• Diagnosis of insulin-requiring diabetes mellitus.
• Current diagnosis of drug or alcohol abuse or history of opioid drug abuse

Sponsors & Collaborators

• University of California, San Francisco: lead

Study Sites (1)

UCSF

San Francisco, California, 94115, United States

Location

Study Officials

• Karin Petersen, MD

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

• Michael C Rowbotham, MD

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: November 16, 2005
• First Posted: November 21, 2005
• Study Start: March 1, 2005
• Primary Completion: December 1, 2006
• Study Completion: December 1, 2006
• Last Updated: April 14, 2011

Record last verified: 2011-03

Locations

US (1)