Trial Outcomes & Findings for Pain Research: Innovative Strategies With Marijuana (NCT NCT03522324)

NCT ID: NCT03522324

Last Updated: 2025-08-27

Results Overview

The Roland Morris Disability Questionnaire assesses self-rated physical disability caused by low back pain. Scores range from 0 to 24, with higher scores indicating more pain interference.

Recruitment status

COMPLETED

Target enrollment

268 participants

Primary outcome timeframe

Change over two time points over 2 weeks: Baseline (before 2 weeks of edible use), Pre-Administration (after 2 weeks of use and before acute administration) using the total RMDQ score (0-24).

Results posted on

2025-08-27

Participant Flow

Note: 268 participants were consented for the study. Among those, 253 submitted photos of their experimental product and were thus assigned to product groups. It is not possible to "group" the 15 participants lost to attrition at that point in the study flow.

Participant milestones

Participant milestones
Measure
THC Group
Participants used THC dominant products
CBD Group
Participants used CBD dominant products
THC+CBD Group
Participants used products with roughly equivalent proportions of THC and CBD
Overall Study
STARTED
38
97
118
Overall Study
COMPLETED
36
96
117
Overall Study
NOT COMPLETED
2
1
1

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Pain Research: Innovative Strategies With Marijuana

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
THC Group
n=36 Participants
Participants used THC dominant products
CBD Group
n=96 Participants
Participants used CBD dominant products
THC+CBD Group
n=117 Participants
Participants used products with roughly equivalent proportions of THC and CBD
Total
n=249 Participants
Total of all reporting groups
Age, Continuous
36.92 years
STANDARD_DEVIATION 15.02 • n=93 Participants
50.18 years
STANDARD_DEVIATION 14.49 • n=4 Participants
46.06 years
STANDARD_DEVIATION 16.38 • n=27 Participants
46.3 years
STANDARD_DEVIATION 16.1 • n=483 Participants
Sex/Gender, Customized
Female
15 Participants
n=93 Participants
58 Participants
n=4 Participants
68 Participants
n=27 Participants
141 Participants
n=483 Participants
Sex/Gender, Customized
Male
20 Participants
n=93 Participants
37 Participants
n=4 Participants
47 Participants
n=27 Participants
104 Participants
n=483 Participants
Sex/Gender, Customized
Transgender/non-binary
1 Participants
n=93 Participants
1 Participants
n=4 Participants
2 Participants
n=27 Participants
4 Participants
n=483 Participants
Ethnicity (NIH/OMB)
Hispanic or Latino
3 Participants
n=93 Participants
3 Participants
n=4 Participants
11 Participants
n=27 Participants
17 Participants
n=483 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
33 Participants
n=93 Participants
92 Participants
n=4 Participants
105 Participants
n=27 Participants
230 Participants
n=483 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants
n=93 Participants
1 Participants
n=4 Participants
1 Participants
n=27 Participants
2 Participants
n=483 Participants
Region of Enrollment
United States
36 participants
n=93 Participants
96 participants
n=4 Participants
117 participants
n=27 Participants
249 participants
n=483 Participants
Pain Intensity
3.2 units on a scale
STANDARD_DEVIATION 0.93 • n=93 Participants
3.37 units on a scale
STANDARD_DEVIATION 0.92 • n=4 Participants
3.45 units on a scale
STANDARD_DEVIATION 0.97 • n=27 Participants
3.4 units on a scale
STANDARD_DEVIATION 0.94 • n=483 Participants

PRIMARY outcome

Timeframe: Change over two time points over 2 weeks: Baseline (before 2 weeks of edible use), Pre-Administration (after 2 weeks of use and before acute administration) using the total RMDQ score (0-24).

The Roland Morris Disability Questionnaire assesses self-rated physical disability caused by low back pain. Scores range from 0 to 24, with higher scores indicating more pain interference.

Outcome measures

Outcome measures
Measure
THC Group
n=36 Participants
Participants used THC dominant products
CBD Group
n=96 Participants
Participants used CBD dominant products
THC+CBD Group
n=117 Participants
Participants used products with roughly equivalent proportions of THC and CBD
Pain Interference: Roland Morris Disability Questionnaire (RMDQ)
Baseline Pain Interference
8.028 score on a scale
Standard Deviation 3.582
9.635 score on a scale
Standard Deviation 4.98
9.034 score on a scale
Standard Deviation 4.495
Pain Interference: Roland Morris Disability Questionnaire (RMDQ)
Pain Interference at 2 Weeks
6.194 score on a scale
Standard Deviation 4.407
8.031 score on a scale
Standard Deviation 5.428
7.419 score on a scale
Standard Deviation 4.796

PRIMARY outcome

Timeframe: Change over two time points over 2 weeks: Baseline (before 2 weeks of edible use) and Pre-Administration (after 2 weeks of use and before acute administration).

Tests levels of recent inflammation (panel of inflammatory markers) before and after cannabis use. Higher numbers indicate higher levels of circulating pro-inflammatory cytokines. Results are in pg/mL and are separated by the three cytokines: IL-1b, IL-6, and IL-10.

Outcome measures

Outcome measures
Measure
THC Group
n=25 Participants
Participants used THC dominant products
CBD Group
n=79 Participants
Participants used CBD dominant products
THC+CBD Group
n=96 Participants
Participants used products with roughly equivalent proportions of THC and CBD
Inflammation: Circulating Levels of Cytokines
Baseline IL-1b blood levels
6.685 pg/mL
Standard Deviation 9.261
8.422 pg/mL
Standard Deviation 13.766
7.829 pg/mL
Standard Deviation 11.214
Inflammation: Circulating Levels of Cytokines
IL-1b Blood Levels at 2 Weeks
6.816 pg/mL
Standard Deviation 9.138
8.031 pg/mL
Standard Deviation 13.274
8.014 pg/mL
Standard Deviation 11.831
Inflammation: Circulating Levels of Cytokines
Baseline IL-6 Blood Levels
3.071 pg/mL
Standard Deviation 2.769
3.994 pg/mL
Standard Deviation 4.438
3.538 pg/mL
Standard Deviation 3.538
Inflammation: Circulating Levels of Cytokines
IL-6 Blood Levels at 2 Weeks
3.101 pg/mL
Standard Deviation 3.091
3.639 pg/mL
Standard Deviation 4.542
3.168 pg/mL
Standard Deviation 2.979
Inflammation: Circulating Levels of Cytokines
Baseline IL-10 Blood Levels
6.183 pg/mL
Standard Deviation 8.65
7.362 pg/mL
Standard Deviation 12.256
8.565 pg/mL
Standard Deviation 13.513
Inflammation: Circulating Levels of Cytokines
IL-10 Blood Levels at 2 Weeks
6.184 pg/mL
Standard Deviation 8.546
7.007 pg/mL
Standard Deviation 12.337
8.563 pg/mL
Standard Deviation 13.842

PRIMARY outcome

Timeframe: Change over two time points over 2 weeks: Baseline (before 2 weeks of edible use), Pre-Administration (after 2 weeks of use and before acute administration).

Co-outcomes testing cognitive impairment in the domains of immediate and delayed recall (ISLT) and attention and inhibitory control (FICA). Cognitive outcomes are measured in standard scores (e.g. Range of \>70 to \>140 (Mean of 100 and SD of 15) with higher scores indicating better performance) and can be averaged to reflect a Standard score of overall cognitive function.

Outcome measures

Outcome measures
Measure
THC Group
n=36 Participants
Participants used THC dominant products
CBD Group
n=93 Participants
Participants used CBD dominant products
THC+CBD Group
n=117 Participants
Participants used products with roughly equivalent proportions of THC and CBD
Flanker Inhibitory Control Attention Task (FICA) & International Shopping List Task (ISLT)
Baseline Flanker Scores
101.806 score on a scale
Standard Deviation 6.528
98.606 score on a scale
Standard Deviation 7.355
99.974 score on a scale
Standard Deviation 8.074
Flanker Inhibitory Control Attention Task (FICA) & International Shopping List Task (ISLT)
2 Week Flanker Scores
102.667 score on a scale
Standard Deviation 6.963
100.207 score on a scale
Standard Deviation 6.657
101.063 score on a scale
Standard Deviation 8.326
Flanker Inhibitory Control Attention Task (FICA) & International Shopping List Task (ISLT)
Baseline ISLT Scores
99.886 score on a scale
Standard Deviation 14.652
98.499 score on a scale
Standard Deviation 12.514
102.37 score on a scale
Standard Deviation 16.359
Flanker Inhibitory Control Attention Task (FICA) & International Shopping List Task (ISLT)
2 Week ISLT Scores
99.756 score on a scale
Standard Deviation 16.278
98.325 score on a scale
Standard Deviation 13.744
100.321 score on a scale
Standard Deviation 16.206

PRIMARY outcome

Timeframe: Change over two time points over 2 weeks: Baseline (before 2 weeks of edible use), Pre-Administration (after 2 weeks of use and before acute administration).

Subjective report of cognitive function using the Perceived Cognitive Impairments subscale of the Functional Assessment of Cancer Therapy Cognitive Scale (FACT-Cog). Possible scores range from 0-80 where higher scores are associated with higher levels of perceived impairment.

Outcome measures

Outcome measures
Measure
THC Group
n=36 Participants
Participants used THC dominant products
CBD Group
n=96 Participants
Participants used CBD dominant products
THC+CBD Group
n=117 Participants
Participants used products with roughly equivalent proportions of THC and CBD
Functional Assessment of Cancer Therapy Cognitive Scale (FACT-Cog)
2 Week Perceived Impairments Rating
12.52 score on a scale
Standard Deviation 9.913
14.037 score on a scale
Standard Deviation 12.77
12.743 score on a scale
Standard Deviation 10.155
Functional Assessment of Cancer Therapy Cognitive Scale (FACT-Cog)
Baseline Perceived Impairments Rating
15.528 score on a scale
Standard Deviation 11.388
14.14 score on a scale
Standard Deviation 11.834
13.978 score on a scale
Standard Deviation 11.226

SECONDARY outcome

Timeframe: Change over 2 weeks

Test effects of cannabinoids on pain using the NIH Pain intensity scale for "current pain" (on a scale from 0-10 with 10 being the worst).

Outcome measures

Outcome measures
Measure
THC Group
n=36 Participants
Participants used THC dominant products
CBD Group
n=96 Participants
Participants used CBD dominant products
THC+CBD Group
n=117 Participants
Participants used products with roughly equivalent proportions of THC and CBD
Pain Intensity: Current Pain Using NIH Pain Intensity Scale.
Baseline Pain Intensity Rating
2.2 score on a scale
Standard Deviation 0.933
2.366 score on a scale
Standard Deviation 0.918
2.448 score on a scale
Standard Deviation 0.972
Pain Intensity: Current Pain Using NIH Pain Intensity Scale.
2-Week Pain Intensity Rating
3.091 score on a scale
Standard Deviation 1.792
3.204 score on a scale
Standard Deviation 1.948
3.288 score on a scale
Standard Deviation 2.064

SECONDARY outcome

Timeframe: Change over 2 weeks

Self-report measure across primary domains of diet, assessment of sleep quality, and health-related well-being. Each domain was assessed with the following single items: Diet: "In general, how healthy is your overall diet? Would you say" (response options 0- excellent; 1- very good; 2- good; 3- fair; 4- poor) Sleep Quality: "During the past 2 weeks, how would you rate your sleep quality overall?" (response options 0- very good; 1- fairly good; 2- fairly bad; 3- very bad") Health Related Wellbeing: "In general, how would you describe your health?" (response options 0- excellent; 1- very good; 2- good; 3- fair; 4- poor)

Outcome measures

Outcome measures
Measure
THC Group
n=36 Participants
Participants used THC dominant products
CBD Group
n=96 Participants
Participants used CBD dominant products
THC+CBD Group
n=117 Participants
Participants used products with roughly equivalent proportions of THC and CBD
Health & Wellbeing
Baseline Self Reported Diet
1.58 units on a scale
Standard Deviation 0.94
1.56 units on a scale
Standard Deviation 0.96
1.44 units on a scale
Standard Deviation 0.92
Health & Wellbeing
2 Week Self Reported Diet
1.54 units on a scale
Standard Deviation 0.90
1.64 units on a scale
Standard Deviation 0.82
1.50 units on a scale
Standard Deviation 0.96
Health & Wellbeing
Baseline Sleep Quality
1.31 units on a scale
Standard Deviation 0.79
1.27 units on a scale
Standard Deviation 0.72
1.22 units on a scale
Standard Deviation 0.67
Health & Wellbeing
2 Week Sleep Quality
1.00 units on a scale
Standard Deviation 0.66
1.19 units on a scale
Standard Deviation 0.63
1.06 units on a scale
Standard Deviation 0.61
Health & Wellbeing
Baseline Health-Related Wellbeing
1.58 units on a scale
Standard Deviation 0.84
1.52 units on a scale
Standard Deviation 0.88
1.39 units on a scale
Standard Deviation 0.79
Health & Wellbeing
2 Week Health-Related Wellbeing
1.44 units on a scale
Standard Deviation 0.95
1.55 units on a scale
Standard Deviation 0.83
1.49 units on a scale
Standard Deviation 0.76

SECONDARY outcome

Timeframe: Change over 4 weeks

The Pittsburgh Sleep Quality Assessment (PSQI) is a self-report assessment of sleep quality.9 self-reported items belongs to one of seven subcategories: subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleeping medication, and daytime dysfunction. Scores for each question range from 0 to 3, with higher scores indicating more acute sleep disturbances (Scores range from 0 to 21 overall, with scores greater than 5 suggesting significant sleep difficulties).

Outcome measures

Outcome measures
Measure
THC Group
n=36 Participants
Participants used THC dominant products
CBD Group
n=96 Participants
Participants used CBD dominant products
THC+CBD Group
n=117 Participants
Participants used products with roughly equivalent proportions of THC and CBD
Pittsburgh Sleep Quality Assessment (PSQI)
Baseline PSQI Scores
8.22 score on a scale
Standard Deviation 3.54
8.39 score on a scale
Standard Deviation 3.67
7.46 score on a scale
Standard Deviation 3.87
Pittsburgh Sleep Quality Assessment (PSQI)
4 Week PSQI Scores
5.85 score on a scale
Standard Deviation 3.09
7.07 score on a scale
Standard Deviation 3.74
6.14 score on a scale
Standard Deviation 3.42

SECONDARY outcome

Timeframe: Change over 2 weeks

Motor control assessed via dynamic sway and proprioception. Motor outcomes were aggregated to reflect a Z-score of overall motor function. Scores reported below are sum of Motor Battery Balance z-scores (Eyes Open, Eyes Closed, and Head Back). Higher scores correspond to worse balance- there is not a maximum score.

Outcome measures

Outcome measures
Measure
THC Group
n=32 Participants
Participants used THC dominant products
CBD Group
n=93 Participants
Participants used CBD dominant products
THC+CBD Group
n=109 Participants
Participants used products with roughly equivalent proportions of THC and CBD
Motor Function
Baseline z-score
0.019 z-score
Standard Deviation 0.006
0.023 z-score
Standard Deviation 0.013
0.021 z-score
Standard Deviation 0.007
Motor Function
2 Week z-score
0.018 z-score
Standard Deviation 0.006
0.023 z-score
Standard Deviation 0.011
0.02 z-score
Standard Deviation 0.006

SECONDARY outcome

Timeframe: Change over 2 weeks

The DASS21 is a 21-item scale that measures self-reported change in anxiety, depression, and stress symptoms. Participants are asked to use 4-point severity/frequency scales (higher values indicate greater severity) to rate the extent to which they have experienced each state. For this aim, the Depression and Stress subscales were used. Depression subscale score range 0-21 Normal (0 to 4), Mild (5 to 6), Moderate, (7 to 10), Severe (11 to 13), Extremely Severe (14 and above) Stress subscale score range 0-33 Normal (0 to 14), Mild (15 to 18), Moderate, (19 to 25), Severe (26 to 33)

Outcome measures

Outcome measures
Measure
THC Group
n=36 Participants
Participants used THC dominant products
CBD Group
n=96 Participants
Participants used CBD dominant products
THC+CBD Group
n=117 Participants
Participants used products with roughly equivalent proportions of THC and CBD
Depression and Stress
Baseline Depression score
7.111 score on a scale
Standard Deviation 6.369
6.188 score on a scale
Standard Deviation 7.41
6.872 score on a scale
Standard Deviation 8.197
Depression and Stress
2 Week Depression Score
5.939 score on a scale
Standard Deviation 7.132
5.532 score on a scale
Standard Deviation 6.508
5.856 score on a scale
Standard Deviation 7.364
Depression and Stress
Baseline Stress Score
9.667 score on a scale
Standard Deviation 7.716
9.417 score on a scale
Standard Deviation 8.135
10.068 score on a scale
Standard Deviation 7.991
Depression and Stress
2 Week Stress Score
8.545 score on a scale
Standard Deviation 7.023
8.596 score on a scale
Standard Deviation 8.042
8.198 score on a scale
Standard Deviation 6.959

SECONDARY outcome

Timeframe: 2 Weeks

Co-outcomes testing cognitive impairment after acute use of cannabis in the domains of immediate and delayed recall (ISLT) and and attention and inhibitory control (FICA). Cognitive outcomes are measured in standard scores (e.g. Range of \<70 to \>140 (Mean of 100 and SD of 15) with higher scores indicating better performance) and can be averaged to reflect a Standard score of overall cognitive function.

Outcome measures

Outcome measures
Measure
THC Group
n=36 Participants
Participants used THC dominant products
CBD Group
n=93 Participants
Participants used CBD dominant products
THC+CBD Group
n=117 Participants
Participants used products with roughly equivalent proportions of THC and CBD
Acute Cognitive Impairment: Flanker Inhibitory Control Attention Task (FICA) and International Shopping List Task (ISLT).
Baseline Sum Cognitive Score
100.619 standard score
Standard Deviation 8.115
98.281 standard score
Standard Deviation 7.694
100.904 standard score
Standard Deviation 10.296
Acute Cognitive Impairment: Flanker Inhibitory Control Attention Task (FICA) and International Shopping List Task (ISLT).
2 Week Sum Cognitive Score
101.675 standard score
Standard Deviation 9.226
99.615 standard score
Standard Deviation 8.166
100.91 standard score
Standard Deviation 9.944

SECONDARY outcome

Timeframe: Change over 2 week primary exposure period.

Patient Global Impression of Change Scale (PGIC) measures self-reported change on a 1-7 scale (i.e. from 1 (very much worse) to 7 (very much improved) in pain. Changes in this measure will be tested in relation to THC and CBD blood levels. Scale possible score range 1-7, with higher scores indicating the largest amount of possible change. Importantly, it is a subjective self-assessment of change and is only measured at the 2 week timepoint.

Outcome measures

Outcome measures
Measure
THC Group
n=33 Participants
Participants used THC dominant products
CBD Group
n=94 Participants
Participants used CBD dominant products
THC+CBD Group
n=111 Participants
Participants used products with roughly equivalent proportions of THC and CBD
Patient Global Impression of Change: Global Impression of Change Scale (PGIC).
4.97 score on a scale
Standard Deviation 0.847
4.745 score on a scale
Standard Deviation 0.867
4.856 score on a scale
Standard Deviation 0.862

OTHER_PRE_SPECIFIED outcome

Timeframe: 2 weeks (daily)

Brief self-report from participants on pain and sleep in the past 24 hours. These are 1-item novel questions in a daily, text based survey. Pain and sleep are on a scale of 1-10, with higher numbers being more pain or better sleep. Score is an average rating over 14 days.

Outcome measures

Outcome measures
Measure
THC Group
n=36 Participants
Participants used THC dominant products
CBD Group
n=96 Participants
Participants used CBD dominant products
THC+CBD Group
n=116 Participants
Participants used products with roughly equivalent proportions of THC and CBD
Exploratory: Daily Follow-up Messages
Pain Rating
2.989 units on a scale
Standard Deviation 1.848
3.247 units on a scale
Standard Deviation 2.033
3.322 units on a scale
Standard Deviation 2.083
Exploratory: Daily Follow-up Messages
Sleep Rating
5.426 units on a scale
Standard Deviation 1.823
4.916 units on a scale
Standard Deviation 1.657
5.193 units on a scale
Standard Deviation 1.801

OTHER_PRE_SPECIFIED outcome

Timeframe: 6 months (monthly)

Self-report from participants on pain levels (0-10 with 10 being worst pain), sleep quality (0-10 with 10 being best sleep), perceived cognitive ability (0 - 27 with 27 being the best), perceived cognitive impairments (0-72 with 72 being the worst), and general health (0-4 with 4 being best). Scores are reported as average scores reported once a month over six months.

Outcome measures

Outcome measures
Measure
THC Group
n=33 Participants
Participants used THC dominant products
CBD Group
n=89 Participants
Participants used CBD dominant products
THC+CBD Group
n=105 Participants
Participants used products with roughly equivalent proportions of THC and CBD
Exploratory: Monthly Follow-up Surveys
Monthly Pain Rating
3.067 units on a scale
Standard Deviation 3.15
2.844 units on a scale
Standard Deviation 2.974
3.216 units on a scale
Standard Deviation 3.153
Exploratory: Monthly Follow-up Surveys
Monthly Sleep Quality
5.763 units on a scale
Standard Deviation 1.79
5.837 units on a scale
Standard Deviation 1.708
5.595 units on a scale
Standard Deviation 1.626
Exploratory: Monthly Follow-up Surveys
Monthly Perceived Cognitive Ability
18.78 units on a scale
Standard Deviation 6.152
19.408 units on a scale
Standard Deviation 6.134
18.473 units on a scale
Standard Deviation 6.612
Exploratory: Monthly Follow-up Surveys
Monthly Perceived Cognitive Impairments
5.756 units on a scale
Standard Deviation 10.222
4.88 units on a scale
Standard Deviation 7.918
7.718 units on a scale
Standard Deviation 14.185
Exploratory: Monthly Follow-up Surveys
Monthly General Health Rating
1.367 units on a scale
Standard Deviation 0.893
1.606 units on a scale
Standard Deviation 0.745
1.588 units on a scale
Standard Deviation 0.777

OTHER_PRE_SPECIFIED outcome

Timeframe: 2 weeks

Physical activity via objective daily data on wearable watch as measured by average minutes of moderate to vigorous physical activity (MVPA).

Outcome measures

Outcome measures
Measure
THC Group
n=31 Participants
Participants used THC dominant products
CBD Group
n=82 Participants
Participants used CBD dominant products
THC+CBD Group
n=94 Participants
Participants used products with roughly equivalent proportions of THC and CBD
Objective Physical Activity/Exercise
1610.258 minutes
Standard Deviation 773.122
1830.455 minutes
Standard Deviation 1103.797
1723.745 minutes
Standard Deviation 1081.798

OTHER_PRE_SPECIFIED outcome

Timeframe: 2 weeks

Physical activity via subjective self-report data using the Stanford Leisure-Time Activity Categorical item with 6 item responses (L-CAT; 1-6). Scores are reported as a mean between 1 and 6, larger numbers correspond to higher levels of activity.

Outcome measures

Outcome measures
Measure
THC Group
n=36 Participants
Participants used THC dominant products
CBD Group
n=96 Participants
Participants used CBD dominant products
THC+CBD Group
n=117 Participants
Participants used products with roughly equivalent proportions of THC and CBD
Physical Activity/Exercise
Baseline Physical Activity
3.806 score on a scale
Standard Deviation 1.39
3.417 score on a scale
Standard Deviation 1.202
3.573 score on a scale
Standard Deviation 1.328
Physical Activity/Exercise
2 Week Physical Activity
3.788 score on a scale
Standard Deviation 1.293
3.277 score on a scale
Standard Deviation 1.177
3.279 score on a scale
Standard Deviation 1.097

Adverse Events

THC Group

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

CBD Group

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

THC+CBD Group

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. L. Cinnamon Bidwell

University of Colorado Boulder

Phone: 3037355180

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place