Discontinuation From Chronic Opioid Therapy For Pain Using a Buprenorphine Taper

For Phase II, the primary outcome measure will be number of participants opioid who achieve cessation 8 weeks after stabilization at Week 10, evidenced as a score of 3 points when summing the following measures: self-report of no opioid use = 1 point; prescription drug monitoring data showing no opioid prescriptions filled in past 30 days = 1 point; and confirmatory negative urine toxicology for a full panel of opioids = 1 point.

Time frame: 8 weeks after stabilization at Week 10

For Phase I, the primary outcome measure is the percentage of patients who tolerate buprenorphine initiation within an 8-hour initiation period, as evidenced by a total score of 3 points when summing the following measures (1) moderate-good level of pain control (same or improved rating on a 0-10 visual analogue scale for pain) = 1 point, (2) mild to no withdrawal symptoms (≤10 on the Subjective Opioid Withdrawal Scale) = 1 point, and (3) willingness to continue to the stabilization and tapering phase of the study; yes = 1 point.

Time frame: 8 hours post dose

COMM is a 17 item questionnaire that is used to examine concurrent misuse. The score range is from 0-28. A lower score represents participant showing less aberrant behaviors associates with misuse of option medications, and a higher score represents more aberrant behaviors associated with opioid medical misuse.

Time frame: Baseline

Population: One person erroneously randomized to placebo before eligible for induction and who never completed buprenorphine induction not considered in this analysis.

The Mean score of Physical Function on PROMIS short form. The global physical health score is a sum of responses to 4 questions. The range is from 4-20. A lower score represents lower physical function. The following questions will be asked: In general, how would you rate your physical health? (range is 1-5; 1 represents poor rating in health, 5 represents excellent rating of physical health) To what extent are you able to carry out your everyday physical activities such as walking, climbing stairs, carrying groceries, or moving a chair? (range is 1-5; 1 represents score of not at all, 5 represents score of completely) How would you rate your fatigue on average? (range is 1-5; 1 represents very severe fatigue, and 5 represents no fatigue) How would you rate your pain on average (range is 0-10; 0 represents no pain, 10 represents worst pain imaginable). The pain score is then recoded: 0, no pain = 5; 1, 2, or 3 = 4; 4, 5, or 6 =3; 7, 8, 9 =2;10 =1

Time frame: baseline

Population: This form was introduced after the first 2 participants had been randomized, so we only have this data for the 24 who were randomized after buprenorphine induction (vs n=26 for other outcome measures). One person was erroneously randomized prior to eligibility for randomization and was not included in calculations for these secondary outcomes.

The Subjective Opiate Withdrawal Scale (SOWS) consist of 16 symptoms rated in intensity by patients on a 5-point scale of intensity as follows: 0=not at all, 1=a little, 2=moderately, 3=quite a bit, 4=extremely. The total score is a sum of item ratings, and ranges from 0 to 64.

Time frame: baseline

The PSQI is a 19 item self-report questionnaire that assesses sleep quality over a 1-month time interval. The measure consists of 19 individual items, creating 7 components (time gone to bed, how long it takes to go to sleep, wake up time, hours slept, issues sleeping, total hours slept etc.) that produce one global score. Each item is weighted on a 0-3 interval scale. The global score is calculated by totaling the seven component scores, providing an overall score ranging from 0 to 21, A lower scale is indicative of better sleep quality and higher score represents poor sleep quality.

Time frame: baseline

Population: One person erroneously randomized not included

Opioid cessation is evidenced as a score of 3 points when summing the following measures: self-report of no opioid use = 1 point; prescription drug monitoring data showing no opioid prescriptions filled in past 30 days = 1 point; and confirmatory negative urine toxicology for a full panel of opioids = 1 point.

Time frame: Post-taper - 12 months

Population: One person in the Gabapentin + Buprenorphine Taper Arm and Zero people in the Placebo + Buprenorphine Taper Arm completed the study buprenorphine taper.

Opioid cessation is evidenced as a score of 3 points when summing the following measures: self-report of no opioid use = 1 point; prescription drug monitoring data showing no opioid prescriptions filled in past 30 days = 1 point; and confirmatory negative urine toxicology for a full panel of opioids = 1 point.

Time frame: Post-taper - 3 months

Population: One person in the Gabapentin + Buprenorphine Taper Arm completed the study buprenorphine taper and were eligible for analysis. Zero persons in the Placebo + Buprenorphine Taper Arm completed the study buprenoprhine taper and were eligible for analysis.

Opioid cessation is evidenced as a score of 3 points when summing the following measures: self-report of no opioid use = 1 point; prescription drug monitoring data showing no opioid prescriptions filled in past 30 days = 1 point; and confirmatory negative urine toxicology for a full panel of opioids = 1 point.

Time frame: Post-taper - 6 months

Population: One person in the Gabapentin + Buprenorphine Taper Arm completed the study buprenorphine taper, and zero persons in the Placebo + Buprenorphine Taper Arm completed the study buprenorphine taper.

Opioid cessation post taper: 1 month with opioid cessation measured through self-report, prescription drug monitoring data, and confirmatory UDS for a full panel of opioids.

Time frame: 1 month post-taper

Population: Only one person in the Gabapentin + Buprenorphine Taper Arm completed the 8 week study buprenorphine taper, making them eligible for analysis for this secondary outcome measure. Zero people in the Placebo + Buprenorphne Taper Arm completed the study buprenorphine taper.

DNIC will be measured as the percent change in PPTh during the cold pressor tasks relative to baseline. A percent increase represents normal functioning of pain inhibitory processes.

Time frame: Baseline

Population: One person was erroneously randomized to placebo before eligible for randomization, and never completed buprenorphine induction, so they are not considered in this analysis.

Mechanical (Pressure) Pain Threshold Assessment (PPTh): A digital anesthesiometer (IITC Life Sciences ElectroVonFrey) will be used to assess mechanical pain perception. Pain threshold to static mechanical stimuli will be determined by applying the rigid monofilament to the dorsum of each subject's right hand with increasing pressure (10 grams per second) until the participant indicates verbally that the pain threshold has been reached.

Time frame: Baseline

Population: One person was erroneously randomized to placebo before they were eligible for randomization and dropped out prior to induction, so they are not considered in this analysis.

The Self Reporting Pain Catastrophizing scale consists of 13 items scored from 0 to 4. The total possible score is 52. A higher score indicates more catastrophizing thoughts are present. A lower score indicates less catastrophizing thoughts.

Time frame: Baseline

Population: One consented and randomized participant in the Placebo + Buprenorphine Taper Arm was erroneously randomized prior to buprenorphine induction, and dropped out of the study on the day of induction prior to receiving first buprenorphine dose (prior to eligibility for randomization). This participant is not included in this analysis.