Trial Outcomes & Findings for A Depression and Opioid Pragmatic Trial in Pharmacogenetics (Chronic Pain Trial) (NCT NCT05966142)

Last Updated: 2025-05-28

Results Overview

The composite pain intensity score is derived from the 3-time PROMIS (Patient-Reported Outcomes Measurement Information System) pain intensity scale. Composite pain intensity score is the sum of the 3 questions and ranges from 3 (no pain) to 15 (intense pain). Change in composite pain intensity score ranges from -12 (change from the highest level of pain to the lowest level of pain) to 12 (change from the lowest level of pain to the highest level of pain).

Recruitment status

COMPLETED

Study phase

Target enrollment

1048 participants

Primary outcome timeframe

Baseline to 3 months

Results posted on

2025-05-28

Participant Flow

This record is specific to the Chronic Pain Trial within the ADOPT PGx protocol. It only contains the participants consented to the Chronic Pain Trial.

There were 1092 participants consented into the Chronic Pain trial. Of the 1092, 44 were not randomized into the trial and were not assigned to a treatment arm. The remaining 1048 consented participants were randomized and assigned into the treatment arms. The 1048 randomized participants will be described moving forward.

Participant milestones

Participant milestones
Measure	Chronic Pain - Immediate PGx Testing Immediate genetic testing of CYP2D6 and clinical decisions support for pain management prescribing to the healthcare provider.	Chronic Pain - Delayed PGx Testing Delayed genetic testing of CYP2D6 and return of results after the conclusion of the 6-month follow-up period.
Overall Study STARTED	527	521
Overall Study COMPLETED	456	457
Overall Study NOT COMPLETED	71	64

Reasons for withdrawal

Reasons for withdrawal
Measure	Chronic Pain - Immediate PGx Testing Immediate genetic testing of CYP2D6 and clinical decisions support for pain management prescribing to the healthcare provider.	Chronic Pain - Delayed PGx Testing Delayed genetic testing of CYP2D6 and return of results after the conclusion of the 6-month follow-up period.
Overall Study Death	3	3
Overall Study Lost to Follow-up	55	52
Overall Study Physician Decision	1	0
Overall Study Withdrawal by Subject	9	8
Overall Study Duplicate Enrollment	1	0
Overall Study Study Logistical Reason	1	0
Overall Study Unable to complete follow up due to change in health	1	1

Baseline Characteristics

Intent to Treat (ITT) population

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Chronic Pain - Immediate PGx Testing n=527 Participants Immediate genetic testing of CYP2D6 and clinical decisions support for pain management prescribing to the healthcare provider.	Chronic Pain - Delayed PGx Testing n=521 Participants Delayed genetic testing of CYP2D6 and return of results after the conclusion of the 6-month follow-up period.	Total n=1048 Participants Total of all reporting groups
Age, Continuous	58.0 years STANDARD_DEVIATION 10.9 • n=136 Participants • Modified Intent to Treat (mITT) population	57.8 years STANDARD_DEVIATION 11.3 • n=146 Participants • Modified Intent to Treat (mITT) population	57.9 years STANDARD_DEVIATION 11.1 • n=282 Participants • Modified Intent to Treat (mITT) population
Sex: Female, Male Female	95 Participants n=134 Participants • Modified Intent to Treat (mITT) population. Two participants declined to answer.	115 Participants n=146 Participants • Modified Intent to Treat (mITT) population. Two participants declined to answer.	210 Participants n=280 Participants • Modified Intent to Treat (mITT) population. Two participants declined to answer.
Sex: Female, Male Male	39 Participants n=134 Participants • Modified Intent to Treat (mITT) population. Two participants declined to answer.	31 Participants n=146 Participants • Modified Intent to Treat (mITT) population. Two participants declined to answer.	70 Participants n=280 Participants • Modified Intent to Treat (mITT) population. Two participants declined to answer.
Ethnicity (NIH/OMB) Hispanic or Latino	13 Participants n=136 Participants • Modified Intent to Treat (mITT) population	12 Participants n=146 Participants • Modified Intent to Treat (mITT) population	25 Participants n=282 Participants • Modified Intent to Treat (mITT) population
Ethnicity (NIH/OMB) Not Hispanic or Latino	119 Participants n=136 Participants • Modified Intent to Treat (mITT) population	131 Participants n=146 Participants • Modified Intent to Treat (mITT) population	250 Participants n=282 Participants • Modified Intent to Treat (mITT) population
Ethnicity (NIH/OMB) Unknown or Not Reported	4 Participants n=136 Participants • Modified Intent to Treat (mITT) population	3 Participants n=146 Participants • Modified Intent to Treat (mITT) population	7 Participants n=282 Participants • Modified Intent to Treat (mITT) population
Race (NIH/OMB) American Indian or Alaska Native	2 Participants n=136 Participants • Modified Intent to Treat (mITT) population	1 Participants n=146 Participants • Modified Intent to Treat (mITT) population	3 Participants n=282 Participants • Modified Intent to Treat (mITT) population
Race (NIH/OMB) Asian	2 Participants n=136 Participants • Modified Intent to Treat (mITT) population	5 Participants n=146 Participants • Modified Intent to Treat (mITT) population	7 Participants n=282 Participants • Modified Intent to Treat (mITT) population
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=136 Participants • Modified Intent to Treat (mITT) population	0 Participants n=146 Participants • Modified Intent to Treat (mITT) population	0 Participants n=282 Participants • Modified Intent to Treat (mITT) population
Race (NIH/OMB) Black or African American	49 Participants n=136 Participants • Modified Intent to Treat (mITT) population	48 Participants n=146 Participants • Modified Intent to Treat (mITT) population	97 Participants n=282 Participants • Modified Intent to Treat (mITT) population
Race (NIH/OMB) White	66 Participants n=136 Participants • Modified Intent to Treat (mITT) population	75 Participants n=146 Participants • Modified Intent to Treat (mITT) population	141 Participants n=282 Participants • Modified Intent to Treat (mITT) population
Race (NIH/OMB) More than one race	2 Participants n=136 Participants • Modified Intent to Treat (mITT) population	6 Participants n=146 Participants • Modified Intent to Treat (mITT) population	8 Participants n=282 Participants • Modified Intent to Treat (mITT) population
Race (NIH/OMB) Unknown or Not Reported	15 Participants n=136 Participants • Modified Intent to Treat (mITT) population	11 Participants n=146 Participants • Modified Intent to Treat (mITT) population	26 Participants n=282 Participants • Modified Intent to Treat (mITT) population
Region of Enrollment United States	527 Participants n=527 Participants	521 Participants n=521 Participants	1048 Participants n=1048 Participants

PRIMARY outcome

Timeframe: Baseline to 3 months

Population: Modified Intent to Treat (mITT) population with completed baseline and 3-month pain surveys.

Outcome measures

Outcome measures
Measure	Chronic Pain - Immediate PGx Testing n=125 Participants Immediate genetic testing of CYP2D6 and clinical decisions support for pain management prescribing to the healthcare provider.	Chronic Pain - Delayed PGx Testing n=130 Participants Delayed genetic testing of CYP2D6 and return of results after the conclusion of the 6-month follow-up period.
Change in Pain Intensity	-0.7 score on a scale Standard Deviation 2.3	-0.8 score on a scale Standard Deviation 2.4

SECONDARY outcome

Timeframe: Baseline to 3 months

Population: Modified Intent to Treat (mITT) population with completed baseline and 3-month pain surveys.

Ratio of Composite Pain Score at 3 months relative to baseline. Composite pain intensity scores were shifted to range 0-12 and the pain reduction magnitude is reported as the ratio of pain at 3 months relative to pain at baseline using this adjusted scale. Statistical analyses were conducted using the log ratio pain at 3 months relative to pain at baseline. Due to the presence of 0 values in the ratios, the log ratios include a +.5 offset, i.e. log(3-month pain +.5 / baseline pain + 0.5).

Outcome measures

Outcome measures
Measure	Chronic Pain - Immediate PGx Testing n=125 Participants Immediate genetic testing of CYP2D6 and clinical decisions support for pain management prescribing to the healthcare provider.	Chronic Pain - Delayed PGx Testing n=130 Participants Delayed genetic testing of CYP2D6 and return of results after the conclusion of the 6-month follow-up period.
Pain Reduction Magnitude	-0.1 log ratio Standard Deviation 0.4	-0.1 log ratio Standard Deviation 0.5

SECONDARY outcome

Timeframe: Baseline to 3 months

Population: Modified Intent to Treat (mITT) population with completed baseline and 3-month pain surveys.

Clinically significant pain reduction defined as ratio of 3-month composite pain score relative to baseline is \< 0.7, corresponding to a 30% or more improvement in pain scores.

Outcome measures

Outcome measures
Measure	Chronic Pain - Immediate PGx Testing n=125 Participants Immediate genetic testing of CYP2D6 and clinical decisions support for pain management prescribing to the healthcare provider.	Chronic Pain - Delayed PGx Testing n=130 Participants Delayed genetic testing of CYP2D6 and return of results after the conclusion of the 6-month follow-up period.
Number of Participants With Clinically Significant Pain Reduction	17 Participants	27 Participants

SECONDARY outcome

Timeframe: 3 months

Population: Modified Intent to Treat (mITT) participants who indicate having taken a prescription for pain medication in the past 3 months.

The 7-item PROMIS questionnaire assesses the extent to which participant experience prescription pain medication misuse symptoms in the past 3 months using a 5-point Likert scale. Participants are asked if they have had a prescription for pain medication in the last 3 months. If no, the questionnaire is not administered, if yes, the questionnaire is administered. For the completed questionnaires. Raw scores ranging from 7 to 35. Raw scores are converted to T-scores using the PROMIS conversion table, with T-scores ranging 36.3 to 54.1. Higher T-scores reflect greater symptom severity.

Outcome measures

Outcome measures
Measure	Chronic Pain - Immediate PGx Testing n=106 Participants Immediate genetic testing of CYP2D6 and clinical decisions support for pain management prescribing to the healthcare provider.	Chronic Pain - Delayed PGx Testing n=109 Participants Delayed genetic testing of CYP2D6 and return of results after the conclusion of the 6-month follow-up period.
Prescription Pain Medication Misuse as Measured by PROMIS (Patient-Reported Outcomes Measurement Information System)	40.1 T-score Standard Deviation 4.8	40.5 T-score Standard Deviation 4.8

SECONDARY outcome

Timeframe: 3 months

Population: Modified Intent to Treat (mITT) participants with prescription pain medication data collected.

Concordance between the participant reported opioid medications at 3 months and CYP2D6 phenotype.

Outcome measures

Outcome measures
Measure	Chronic Pain - Immediate PGx Testing n=123 Participants Immediate genetic testing of CYP2D6 and clinical decisions support for pain management prescribing to the healthcare provider.	Chronic Pain - Delayed PGx Testing n=133 Participants Delayed genetic testing of CYP2D6 and return of results after the conclusion of the 6-month follow-up period.
Number of Participants With Drug-Gene Concordance	33 Participants	36 Participants

Adverse Events

Chronic Pain - Immediate PGx Testing

Serious events: 0 serious events

Other events: 0 other events

Deaths: 3 deaths

Chronic Pain - Delayed PGx Testing

Serious events: 0 serious events

Other events: 0 other events

Deaths: 3 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Hrishikesh Chakraborty, PhD

Duke University

Phone: 919-668-1238

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place