Trial Outcomes & Findings for Evaluation of an Oral Cannabidiol (CBD)-Terpene Formulation on Sleep Physiology in Participants With Insomnia (NCT NCT05233761)
NCT ID: NCT05233761
Last Updated: 2025-09-11
Results Overview
The primary endpoint is the percentage of time spent in slow wave (Deep) and REM sleep as quantified by a non-invasive wrist-worn sleep-tracking device called Whoop.
COMPLETED
PHASE2
125 participants
Participants were assessed for treatment with CBD-terpenes and placebo, each for a treatment period of four weeks. Participants took the treatment (CBD-terpenes or Placebo) for at least four nights per week over the entire four week treatment period.
2025-09-11
Participant Flow
Participant milestones
| Measure |
Group 1 (A to B: A = Placebo; B = Defined CBD)
The placebo control will be administered as two small capsules that will be taken orally with a glass of water one hour before bedtime that do not contain any CBD or terpenes. Participants will take the treatment on a minimum of four nights per week, over a total of four-weeks. The Placebo capsules look and smell identical to the Defined CBD capsules.
Defined CBD will be administered as two small capsules that will be taken orally with a glass of water one hour before bedtime that contain 300 mg CBD and 8 mg terpenes. Participants will take the treatment on a minimum of four nights per week, over a total of four-weeks.
|
Group 2 (B to A: B = Defined CBD; A = Placebo)
Defined CBD will be administered as two small capsules that will be taken orally with a glass of water one hour before bedtime that contain 300 mg CBD and 8 mg terpenes. Participants will take the treatment on a minimum of four nights per week, over a total of four-weeks.
The placebo control will be administered as two small capsules that will be taken orally with a glass of water one hour before bedtime that do not contain any CBD or terpenes. Participants will take the treatment on a minimum of four nights per week, over a total of four-weeks. The Placebo capsules look and smell identical to the Defined CBD capsules.
|
|---|---|---|
|
Treatment Period A
STARTED
|
63
|
62
|
|
Treatment Period A
COMPLETED
|
37
|
25
|
|
Treatment Period A
NOT COMPLETED
|
26
|
37
|
|
Treatment Period B
STARTED
|
37
|
25
|
|
Treatment Period B
COMPLETED
|
37
|
25
|
|
Treatment Period B
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
| Measure |
Group 1 (A to B: A = Placebo; B = Defined CBD)
The placebo control will be administered as two small capsules that will be taken orally with a glass of water one hour before bedtime that do not contain any CBD or terpenes. Participants will take the treatment on a minimum of four nights per week, over a total of four-weeks. The Placebo capsules look and smell identical to the Defined CBD capsules.
Defined CBD will be administered as two small capsules that will be taken orally with a glass of water one hour before bedtime that contain 300 mg CBD and 8 mg terpenes. Participants will take the treatment on a minimum of four nights per week, over a total of four-weeks.
|
Group 2 (B to A: B = Defined CBD; A = Placebo)
Defined CBD will be administered as two small capsules that will be taken orally with a glass of water one hour before bedtime that contain 300 mg CBD and 8 mg terpenes. Participants will take the treatment on a minimum of four nights per week, over a total of four-weeks.
The placebo control will be administered as two small capsules that will be taken orally with a glass of water one hour before bedtime that do not contain any CBD or terpenes. Participants will take the treatment on a minimum of four nights per week, over a total of four-weeks. The Placebo capsules look and smell identical to the Defined CBD capsules.
|
|---|---|---|
|
Treatment Period A
Withdrawal by Subject
|
12
|
10
|
|
Treatment Period A
Lost to Follow-up
|
6
|
12
|
|
Treatment Period A
Protocol Violation
|
8
|
15
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Group 1 (A to B: A = Placebo; B = Defined CBD)
n=63 Participants
The placebo control will be administered as two small capsules that will be taken orally with a glass of water one hour before bedtime that do not contain any CBD or terpenes. Participants will take the treatment on a minimum of four nights per week, over a total of four-weeks. The Placebo capsules look and smell identical to the Defined CBD capsules.
Defined CBD will be administered as two small capsules that will be taken orally with a glass of water one hour before bedtime that contain 300 mg CBD and 8 mg terpenes. Participants will take the treatment on a minimum of four nights per week, over a total of four-weeks.
|
Group 2 (B to A: B = Defined CBD; A = Placebo)
n=62 Participants
Defined CBD will be administered as two small capsules that will be taken orally with a glass of water one hour before bedtime that contain 300 mg CBD and 8 mg terpenes. Participants will take the treatment on a minimum of four nights per week, over a total of four-weeks.
The placebo control will be administered as two small capsules that will be taken orally with a glass of water one hour before bedtime that do not contain any CBD or terpenes. Participants will take the treatment on a minimum of four nights per week, over a total of four-weeks. The Placebo capsules look and smell identical to the Defined CBD capsules.
|
Total
n=125 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=63 Participants
|
0 Participants
n=62 Participants
|
0 Participants
n=125 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
63 Participants
n=63 Participants
|
62 Participants
n=62 Participants
|
125 Participants
n=125 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=63 Participants
|
0 Participants
n=62 Participants
|
0 Participants
n=125 Participants
|
|
Sex: Female, Male
Female
|
51 Participants
n=63 Participants
|
50 Participants
n=62 Participants
|
101 Participants
n=125 Participants
|
|
Sex: Female, Male
Male
|
12 Participants
n=63 Participants
|
12 Participants
n=62 Participants
|
24 Participants
n=125 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
United States
|
63 participants
n=63 Participants
|
62 participants
n=62 Participants
|
125 participants
n=125 Participants
|
PRIMARY outcome
Timeframe: Participants were assessed for treatment with CBD-terpenes and placebo, each for a treatment period of four weeks. Participants took the treatment (CBD-terpenes or Placebo) for at least four nights per week over the entire four week treatment period.Population: Data from six participants \[four participants from Group 1 (A/B) and two participants from Group 2 (B/A)\] were excluded from the final data analysis due to protocol deviations (e.g. due to a lack of reporting whether or not they took the study treatment, and/or insufficient sleep data collection).
The primary endpoint is the percentage of time spent in slow wave (Deep) and REM sleep as quantified by a non-invasive wrist-worn sleep-tracking device called Whoop.
Outcome measures
| Measure |
Defined CBD
n=56 Participants
Defined CBD will be administered as two small capsules that will be taken orally with a glass of water one hour before bedtime that contain a total of 300 mg CBD and 8 mg terpenes. Participants will take the treatment on a minimum of four nights per week, over a total of four-weeks.
Defined CBD: 300 mg CBD and 8 mg Terpenes administered as two small capsules.
|
Placebo
n=56 Participants
The placebo control will be administered as two small capsules that will be taken orally with a glass of water one hour before bedtime that do not contain any CBD or terpenes. Participants will take the treatment on a minimum of four nights per week, over a total of four-weeks. The Placebo capsules will look and smell identical to the Defined CBD capsules.
Placebo: Capsules that smell and look exactly like Defined CBD but contain no CBD or terpenes.
|
|---|---|---|
|
Percentage of Time Spent in the Combination of Slow Wave Sleep (SWS) and Rapid Eye Movement (REM) Sleep
|
43.0 Percentage of total sleep time
Standard Error 0.4
|
41.8 Percentage of total sleep time
Standard Error 0.4
|
SECONDARY outcome
Timeframe: Four weeksPopulation: Data from six participants \[four participants from Group 1 (A/B) and two participants from Group 2 (B/A)\] were excluded from the final data analysis due to protocol deviations (e.g. due to a lack of reporting whether or not they took the study treatment, and/or insufficient sleep data collection).
The percentage of time spent in each sleep stage (SWS, REM, light and awake) relative to total sleep time as quantified by a non-invasive wrist-worn sleep-tracking device called Whoop.
Outcome measures
| Measure |
Defined CBD
n=56 Participants
Defined CBD will be administered as two small capsules that will be taken orally with a glass of water one hour before bedtime that contain a total of 300 mg CBD and 8 mg terpenes. Participants will take the treatment on a minimum of four nights per week, over a total of four-weeks.
Defined CBD: 300 mg CBD and 8 mg Terpenes administered as two small capsules.
|
Placebo
n=56 Participants
The placebo control will be administered as two small capsules that will be taken orally with a glass of water one hour before bedtime that do not contain any CBD or terpenes. Participants will take the treatment on a minimum of four nights per week, over a total of four-weeks. The Placebo capsules will look and smell identical to the Defined CBD capsules.
Placebo: Capsules that smell and look exactly like Defined CBD but contain no CBD or terpenes.
|
|---|---|---|
|
Objective Secondary Outcome Measures of Sleep Physiology
SWS Sleep (%TST)
|
19.1 Percentage of TST
Standard Error 0.2
|
18.1 Percentage of TST
Standard Error 0.2
|
|
Objective Secondary Outcome Measures of Sleep Physiology
REM Sleep (% TST)
|
24.0 Percentage of TST
Standard Error 0.3
|
23.7 Percentage of TST
Standard Error 0.3
|
|
Objective Secondary Outcome Measures of Sleep Physiology
Light Sleep (% TST)
|
56.0 Percentage of TST
Standard Error 0.4
|
57.7 Percentage of TST
Standard Error 0.4
|
|
Objective Secondary Outcome Measures of Sleep Physiology
Awake Time (% TST)
|
22.4 Percentage of TST
Standard Error 0.5
|
21.7 Percentage of TST
Standard Error 0.4
|
SECONDARY outcome
Timeframe: Four weeksPopulation: Data from six participants \[four participants from Group 1 (A/B) and two participants from Group 2 (B/A)\] were excluded from the final data analysis due to protocol deviations (e.g. due to a lack of reporting whether or not they took the study treatment, and/or insufficient sleep data collection).
The absolute time spent in each sleep stage (SWS, REM, light and awake) as quantified by a non-invasive wrist-worn sleep-tracking device called Whoop.
Outcome measures
| Measure |
Defined CBD
n=56 Participants
Defined CBD will be administered as two small capsules that will be taken orally with a glass of water one hour before bedtime that contain a total of 300 mg CBD and 8 mg terpenes. Participants will take the treatment on a minimum of four nights per week, over a total of four-weeks.
Defined CBD: 300 mg CBD and 8 mg Terpenes administered as two small capsules.
|
Placebo
n=56 Participants
The placebo control will be administered as two small capsules that will be taken orally with a glass of water one hour before bedtime that do not contain any CBD or terpenes. Participants will take the treatment on a minimum of four nights per week, over a total of four-weeks. The Placebo capsules will look and smell identical to the Defined CBD capsules.
Placebo: Capsules that smell and look exactly like Defined CBD but contain no CBD or terpenes.
|
|---|---|---|
|
Objective Secondary Outcome Measures of Sleep Physiology
SWS+REM Sleep (min)
|
162.5 Min
Standard Error 2.0
|
155.0 Min
Standard Error 2.2
|
|
Objective Secondary Outcome Measures of Sleep Physiology
SWS Sleep (min)
|
71.1 Min
Standard Error 0.9
|
67.7 Min
Standard Error 1.0
|
|
Objective Secondary Outcome Measures of Sleep Physiology
REM Sleep (min)
|
91.4 Min
Standard Error 1.4
|
90.0 Min
Standard Error 1.5
|
|
Objective Secondary Outcome Measures of Sleep Physiology
Light Sleep (min)
|
206.2 Min
Standard Error 2.5
|
212.9 Min
Standard Error 2.6
|
|
Objective Secondary Outcome Measures of Sleep Physiology
Awake Time (min)
|
80.4 Min
Standard Error 1.7
|
78.2 Min
Standard Error 1.7
|
|
Objective Secondary Outcome Measures of Sleep Physiology
Total Sleep Time (min)
|
366.5 Min
Standard Error 3.3
|
373.4 Min
Standard Error 3.3
|
SECONDARY outcome
Timeframe: Participants were assessed for treatment with CBD-terpenes and placebo, each for a treatment period of four weeks. Participants took the treatment (CBD-terpenes or Placebo) for at least four nights per week over the entire four week treatment period.Population: Data from six participants \[four participants from Group 1 (A/B) and two participants from Group 2 (B/A)\] were excluded from the final data analysis due to protocol deviations (e.g. due to a lack of reporting whether or not they took the study treatment, and/or insufficient sleep data collection).
A modified version of a clinically validated questionnaire/survey entitled the patient's global impression (PGI) was used to assess subjective perceptions of sleep by the study participants after each four-week treatment period. The modified PGI is a five-item, subjective, participant self-report that assesses treatment benefit to sleep quality (Item 1), sleep induction (Item 2), sleep duration (Item 3), sleep depth (Item 4) and treatment effect on the presence of vivid dreams (item 5). Each item in our modified PGI was presented as a survey that consisted of a ten-point categorical scale, with scores between 6-10 representing a treatment benefit/advantage, a score of 5 representing no effect of treatment, and a score of 1-4 representing a treatment worsening/disadvantage.
Outcome measures
| Measure |
Defined CBD
n=56 Participants
Defined CBD will be administered as two small capsules that will be taken orally with a glass of water one hour before bedtime that contain a total of 300 mg CBD and 8 mg terpenes. Participants will take the treatment on a minimum of four nights per week, over a total of four-weeks.
Defined CBD: 300 mg CBD and 8 mg Terpenes administered as two small capsules.
|
Placebo
n=56 Participants
The placebo control will be administered as two small capsules that will be taken orally with a glass of water one hour before bedtime that do not contain any CBD or terpenes. Participants will take the treatment on a minimum of four nights per week, over a total of four-weeks. The Placebo capsules will look and smell identical to the Defined CBD capsules.
Placebo: Capsules that smell and look exactly like Defined CBD but contain no CBD or terpenes.
|
|---|---|---|
|
Subjective Secondary Outcome Measure of Sleep Physiology
Sleep Better
|
5.9 Units on a scale
Standard Error 0.4
|
5.6 Units on a scale
Standard Error 0.4
|
|
Subjective Secondary Outcome Measure of Sleep Physiology
Sleep Induction
|
5.6 Units on a scale
Standard Error 0.4
|
5.1 Units on a scale
Standard Error 0.4
|
|
Subjective Secondary Outcome Measure of Sleep Physiology
Sleep Duration
|
5.6 Units on a scale
Standard Error 0.4
|
4.8 Units on a scale
Standard Error 0.4
|
|
Subjective Secondary Outcome Measure of Sleep Physiology
Sleep Depth
|
5.5 Units on a scale
Standard Error 0.4
|
5.0 Units on a scale
Standard Error 0.4
|
|
Subjective Secondary Outcome Measure of Sleep Physiology
Vivid Dreams
|
4.5 Units on a scale
Standard Error 0.5
|
4.0 Units on a scale
Standard Error 0.5
|
Adverse Events
Defined CBD
Placebo
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place