Structured Discontinuation vs Continued Therapy in Suboptimal and Optimal Responders to High-dose Long-term Opioids for Chronic Pain



Status:Recruiting
Conditions:Psychiatric, Gastrointestinal
Therapuetic Areas:Gastroenterology, Psychiatry / Psychology
Healthy:No
Age Range:18 - 75
Updated:9/1/2017
Contact:Member Companies of the Opioid PMR Consortium
Email:CTinfo@opcstudy.com
Phone:888.969.3775

Use our guide to learn which trials are right for you!

A Randomized, Double-blind, Placebo-controlled, Clinical Trial of Structured Opioid Discontinuation Versus Continued Opioid Therapy in Suboptimal and Optimal Responders to High-dose Long-term Opioid Analgesic Therapy for Chronic Pain.

The purpose of this study is to evaluate the effect on pain intensity (PI) of structured
discontinuation of long-term opioid analgesic therapy compared to continuation of opioid
therapy in Suboptimal and Optimal Responders to high-dose, long-term opioid analgesic therapy
for chronic low back pain (CLBP).


Inclusion Criteria:

1. Be male or non-pregnant, non-lactating female aged 18 to 75 years, inclusive.

2. Have a clinical diagnosis of non-radicular CLBP (pain that occurs in an area with
boundaries between the lowest rib and the crease of the buttocks) of Class 1 or
proximal radicular (above the knee) pain of Class 2 based on the Quebec Task Force
Classification for Spinal Disorders (subjects with previous surgery or chronic pain
syndrome, i.e., classes 9.2 or 10, will be allowed if their pain does not radiate or
radiates only proximally) for a minimum of 12 months and

1. For the Suboptimal Responder group, pain must have been present for at least
several hours a day and have an Average PI score of 6-9 on an 11-point NRS within
the past 24 hours of screening.

2. For the Optimal Responder group, subjects must have an Average PI score of 1-4 on
an 11-point NRS within the past 24 hours of screening.

3. Have been taking ER/LA opioids or immediate release opioids (at least 4 times at day)
for at least 12 months.

4. Have been taking one of the 3 index ER opioid drugs around-the-clock at a twice-a-day
frequency for at least 3 consecutive months at a total daily dose within the range
shown below.

Daily Dose Range

1. Morphine sulfate extended-release: 120-540mg

2. Oxycodone extended-release: 80-360mg

3. Oxymorphone extended-release: 40-180mg

5. Be considered, in the opinion of the Investigator, to be in generally good health
other than CLBP at screening based upon the results of a medical history, physical
examination, 12-lead ECG, and laboratory profile.

6. Speak, read, write, and understand English (to reduce heterogeneity of data),
understand the consent form, and be able to effectively communicate with the study
staff.

7. Have access to the Internet (to access the patient support program).

8. Voluntarily provide written informed consent.

9. Be willing and able to complete study procedures.

Exclusion Criteria:

1. Have any clinically significant condition that would, in the opinion of the
Investigator, preclude study participation or interfere with the assessment of pain
and other symptoms of CLBP or increase the risk of opioid-related AEs.

2. Have a primary diagnosis of fibromyalgia, complex regional pain syndrome, neurogenic
claudication due to spinal stenosis, spinal cord compression, acute nerve root
compression, severe or progressive lower extremity weakness or numbness, bowel or
bladder dysfunction as a result of cauda equina compression, diabetic amyotrophy,
meningitis, diskitis, back pain because of secondary infection or tumor, or pain
caused by a confirmed or suspected neoplasm.

3. Have undergone a surgical procedure for back pain within 6 months prior to the
Screening Visit.

4. Have had a nerve or plexus block, including epidural steroid injections or facet
blocks, within 1 month prior to the Screening Visit or botulinum toxin injection in
the lower back region within 3 months prior to screening.

5. Have a history of confirmed malignancy within past 2 years, with exception of basal
cell or squamous cell carcinoma of the skin that has been successfully treated.

6. Have uncontrolled blood pressure, i.e., subject has a sitting systolic blood pressure
>180 mm Hg or <90 mm Hg, or a sitting diastolic blood pressure >110 mmHg or <40 mm Hg
at screening.

7. Have a body mass index (BMI) >45 kg/m2. Anyone with a BMI >40 but <45 with complete a
screening tool (STOPBang Questionnaire) to rule out high risk of obstructive sleep
apnea.

8. Have clinically significant depression based on a score of ≥20 on the Patient Health
Questionnaire (PHQ-8)

9. Have suicidal ideation associated with actual intent and a method or plan in the past
year: "Yes" answers on items 4 or 5 of the Columbia-Suicide Severity Rating Scale
(C-SSRS).

10. Have a previous history of suicidal behaviors in the past 5 years: "Yes" answer (for
events that occurred in the past 5 years) to any of the suicidal behavior items of the
C-SSRS.

11. Have any lifetime history of serious or recurrent suicidal behavior. (Non-suicidal
self-injurious behavior is not a trigger for a risk assessment unless in the
Investigator's judgment it is indicated.)

12. Have clinically significant abnormality in clinical chemistry, hematology or
urinalysis, including serum glutamic-oxaloacetic transaminase/aspartate
aminotransferase or serum glutamic pyruvic transaminase/alanine aminotransferase ≥3
times the upper limit of the reference range or a serum creatinine >2 mg/dL at
screening.

13. Have severe enough psychiatric or substance abuse disorder to compromise the subject's
safety or scientific integrity of the study.

14. Have on-going litigation associated with back pain or pending applications for workers
compensation or disability issues or subjects who plan on filing litigation or claims
within the next 12 months; subjects with settled past litigations will be allowed as
will subjects who have been on workers compensation or disability claims for at least
3 months.

15. Have used a monoamine oxidase inhibitor within 14 days prior to the start of study
medication.

16. Are taking agonist-antagonists (pentazocine, butorphanol or nalbuphine),
buprenorphine, methadone, barbiturates, or more than one type of benzodiazepine within
1 month prior to screening.

17. Have a positive UDT for illicit drugs (including marijuana), non-prescribed controlled
substances (opioid or non-opioid), or alcohol at screening.

18. Have taken any investigational drug within 30 days prior to the Screening Visit or are
currently enrolled in another investigational drug study.
We found this trial at
61
sites
Miami, Florida 33126
Phone: 888-969-3775
?
mi
from
Miami, FL
Click here to add this to my saved trials
1897 Palm Beach Lakes Boulevard
West Palm Beach, Florida 33409
561-689-0606
Phone: 888-969-3775
?
mi
from
West Palm Beach, FL
Click here to add this to my saved trials
Blue Island, Illinois
Phone: 888-969-3775
?
mi
from
Blue Island, IL
Click here to add this to my saved trials
Carlsbad, California
Phone: 888-969-3775
?
mi
from
Carlsbad, CA
Click here to add this to my saved trials
12230 Branders Creek Drive
Chester, Virginia 23831
Phone: 888-969-3775
?
mi
from
Chester, VA
Click here to add this to my saved trials
Denver, Colorado 80209
Phone: 888-969-3775
?
mi
from
Denver, CO
Click here to add this to my saved trials
Doral, Florida 33166
Phone: 888-969-3775
?
mi
from
Doral, FL
Click here to add this to my saved trials
Downingtown, Pennsylvania 19335
Phone: 888-969-3775
?
mi
from
Downingtown, PA
Click here to add this to my saved trials
Escondido, California 92025
Phone: 888-969-3775
?
mi
from
Escondido, CA
Click here to add this to my saved trials
Foley, Alabama 36535
Phone: 888-969-3775
?
mi
from
Foley, AL
Click here to add this to my saved trials
Franklin, Ohio 45005
Phone: 888-969-3775
?
mi
from
Franklin, OH
Click here to add this to my saved trials
Hazelwood, Missouri 63042
Phone: 888-969-3775
?
mi
from
Hazelwood, MO
Click here to add this to my saved trials
Hendersonville, Tennessee 37075
Phone: 888-969-3775
?
mi
from
Hendersonville, TN
Click here to add this to my saved trials
Hialeah, Florida 33013
Phone: 888-969-3775
?
mi
from
Hialeah, FL
Click here to add this to my saved trials
Hialeah, Florida
Phone: 888-969-3775
?
mi
from
Hialeah, FL
Click here to add this to my saved trials
Houston, Texas 77089
Phone: 888-969-3775
?
mi
from
Houston, TX
Click here to add this to my saved trials
Houston, Texas 77043
Phone: 888-969-3775
?
mi
from
Houston, TX
Click here to add this to my saved trials
Irvine, California 92614
Phone: 888-969-3775
?
mi
from
Irvine, CA
Click here to add this to my saved trials
Knoxville, Tennessee 37923
Phone: 888-969-3775
?
mi
from
Knoxville, TN
Click here to add this to my saved trials
Laguna Woods, California
Phone: 888-969-3775
?
mi
from
Laguna Woods, CA
Click here to add this to my saved trials
Las Vegas, Nevada 89146
Phone: 888-969-3775
?
mi
from
Las Vegas, NV
Click here to add this to my saved trials
Los Angeles, California 90035
Phone: 888-969-3775
?
mi
from
Los Angeles, CA
Click here to add this to my saved trials
Los Gatos, California 95032
Phone: 888-969-3775
?
mi
from
Los Gatos, CA
Click here to add this to my saved trials
Marietta, Georgia 30060
Phone: 888-969-3775
?
mi
from
Marietta, GA
Click here to add this to my saved trials
Marietta, Georgia
Phone: 888-969-3775
?
mi
from
Marietta, GA
Click here to add this to my saved trials
Miami, Florida 33122
Phone: 888-969-3775
?
mi
from
Miami, FL
Click here to add this to my saved trials
Miami, Florida
Phone: 888-969-3775
?
mi
from
Miami, FL
Click here to add this to my saved trials
Miami Lakes, Florida
Phone: 888-969-3775
?
mi
from
Miami Lakes, FL
Click here to add this to my saved trials
Middleburg Heights, Ohio 44130
Phone: 888-969-3775
?
mi
from
Middleburg Heights, OH
Click here to add this to my saved trials
Mobile, Alabama 36608
Phone: 888-969-3775
?
mi
from
Mobile, AL
Click here to add this to my saved trials
Montclair, California 91763
Phone: 888-969-3775
?
mi
from
Montclair, CA
Click here to add this to my saved trials
Montgomery, Alabama
Phone: 888-969-3775
?
mi
from
Montgomery, AL
Click here to add this to my saved trials
11220 Elm Lane
Mooresville, North Carolina 28277
Phone: 888-969-3775
?
mi
from
Mooresville, NC
Click here to add this to my saved trials
Oceanside, California 92056
Phone: 888-969-3775
?
mi
from
Oceanside, CA
Click here to add this to my saved trials
Oklahoma City, Oklahoma 73116
Phone: 888-969-3775
?
mi
from
Oklahoma City, OK
Click here to add this to my saved trials
Oklahoma City, Oklahoma 73109
Phone: 888-969-3775
?
mi
from
Oklahoma City, OK
Click here to add this to my saved trials
Oklahoma City, Oklahoma 73112
Phone: 888-969-3775
?
mi
from
Oklahoma City, OK
Click here to add this to my saved trials
8675 College Boulevard
Overland Park, Kansas 66210
Phone: 888-969-3775
?
mi
from
Overland Park, KS
Click here to add this to my saved trials
Philadelphia, Pennsylvania 19152
Phone: 888-969-3775
?
mi
from
Philadelphia, PA
Click here to add this to my saved trials
Phoenix, Arizona 85027
Phone: 888-969-3775
?
mi
from
Phoenix, AZ
Click here to add this to my saved trials
Phoenix, Arizona 85028
Phone: 888-969-3775
?
mi
from
Phoenix, AZ
Click here to add this to my saved trials
Placentia, California 92870
Phone: 888-969-3775
?
mi
from
Placentia, CA
Click here to add this to my saved trials
499 Northwest 70th Avenue
Plantation, Florida 33317
Phone: 888-969-3775
?
mi
from
Plantation, FL
Click here to add this to my saved trials
Pomona, California
Phone: 888-969-3775
?
mi
from
Pomona, CA
Click here to add this to my saved trials
Rapid City, South Dakota
Phone: 888-969-3775
?
mi
from
Rapid City, SD
Click here to add this to my saved trials
1445 Johnston Willis Drive
Richmond, Virginia 23235
Phone: 888-969-3775
?
mi
from
Richmond, VA
Click here to add this to my saved trials
Sacramento, California
Phone: 888-969-3775
?
mi
from
Sacramento, CA
Click here to add this to my saved trials
Saint Louis, Missouri 63141
Phone: 888-969-3775
?
mi
from
Saint Louis, MO
Click here to add this to my saved trials
Saint Petersburg, Florida
Phone: 888-969-3775
?
mi
from
Saint Petersburg, FL
Click here to add this to my saved trials
Salt Lake City, Utah 84124
Phone: 888-969-3775
?
mi
from
Salt Lake City, UT
Click here to add this to my saved trials
San Bernardino, California 92408
Phone: 888-969-3775
?
mi
from
San Bernardino, CA
Click here to add this to my saved trials
San Francisco, California 94102
Phone: 888-969-3775
?
mi
from
San Francisco, CA
Click here to add this to my saved trials
1811 East Bert Kouns Industrial Loop
Shreveport, Louisiana 71105
Phone: 888-969-3775
?
mi
from
Shreveport, LA
Click here to add this to my saved trials
South Bend, Indiana
Phone: 888-969-3775
?
mi
from
South Bend, IN
Click here to add this to my saved trials
Spartanburg, South Carolina
Phone: 888-969-3775
?
mi
from
Spartanburg, SC
Click here to add this to my saved trials
5115 North Armenia Avenue
Tampa, Florida 33603
Phone: 888-969-3775
?
mi
from
Tampa, FL
Click here to add this to my saved trials
Troy, Michigan 48085
Phone: 888-969-3775
?
mi
from
Troy, MI
Click here to add this to my saved trials
Tucson, Arizona 85712
Phone: 888-969-3775
?
mi
from
Tucson, AZ
Click here to add this to my saved trials
Watertown, Massachusetts 02472
Phone: 888-969-3775
?
mi
from
Watertown, MA
Click here to add this to my saved trials
Winston-Salem, North Carolina 27103
Phone: 888-969-3775
?
mi
from
Winston-Salem, NC
Click here to add this to my saved trials
Winston-Salem, North Carolina 27103
Phone: 888-969-3775
?
mi
from
Winston-Salem, NC
Click here to add this to my saved trials