Trial Outcomes & Findings for Effect of Ramelteon on Smoking Abstinence (NCT NCT02560324)
NCT ID: NCT02560324
Last Updated: 2019-11-04
Results Overview
The quit assessment will begin the Monday morning of each quit week and will end that Friday. The total number of days of abstinence will be assessed.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
140 participants
Primary outcome timeframe
Week 2 and Week 6
Results posted on
2019-11-04
Participant Flow
697 potential participants were pre-screened over the phone for eligibility between September 2015 and August 2018. 140 potential participants attended an in-person eligibility screen at the research clinic.
69 of 140 participants met eligibility criteria and were randomized. For participants who were not randomized: 61 did not meet inclusion criteria, 5 declined to participate, 4 missed the baseline visit, and 1 is unknown.
Participant milestones
| Measure |
Ramelteon Then Placebo
Participants smoked ad libitum for 1 week and then received 8mg of Ramelteon once per day + transdermal nicotine for 1 week. After a washout period of 2 weeks, participants again smoked ad libitum for 1 week, then received Placebo pills (matching Ramelteon 8mg pills) once per day + transdermal nicotine for 1 week.
|
Placebo Then Ramelteon
Participants smoked ad libitum for 1 week and then received Placebo pills (matching Ramelteon 8mg pills) once per day + transdermal nicotine for 1 week. After a washout period of 2 weeks, participants again smoked ad libitum for 1 week, then received 8mg of Ramelteon once per day + transdermal nicotine for 1 week.
|
|---|---|---|
|
Period 1 (2 Weeks)
STARTED
|
35
|
34
|
|
Period 1 (2 Weeks)
COMPLETED
|
23
|
25
|
|
Period 1 (2 Weeks)
NOT COMPLETED
|
12
|
9
|
|
Washout (2 Weeks)
STARTED
|
23
|
25
|
|
Washout (2 Weeks)
COMPLETED
|
23
|
23
|
|
Washout (2 Weeks)
NOT COMPLETED
|
0
|
2
|
|
Period 2 (2 Weeks)
STARTED
|
23
|
23
|
|
Period 2 (2 Weeks)
COMPLETED
|
22
|
21
|
|
Period 2 (2 Weeks)
NOT COMPLETED
|
1
|
2
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Effect of Ramelteon on Smoking Abstinence
Baseline characteristics by cohort
| Measure |
Ramelteon Then Placebo
n=22 Participants
Participants smoked ad libitum for 1 week and then received 8mg of Ramelteon once per day + transdermal nicotine for 1 week. After a washout period of 2 weeks, participants again smoked ad libitum for 1 week, then received Placebo pills (matching Ramelteon 8mg pills) once per day + transdermal nicotine for 1 week.
|
Placebo Then Ramelteon
n=21 Participants
Participants smoked ad libitum for 1 week and then received Placebo pills (matching Ramelteon 8mg pills) once per day + transdermal nicotine for 1 week. After a washout period of 2 weeks, participants again smoked ad libitum for 1 week, then received 8mg of Ramelteon once per day + transdermal nicotine for 1 week.
|
Total
n=43 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
49.6 years
STANDARD_DEVIATION 8.9 • n=5 Participants
|
52.1 years
STANDARD_DEVIATION 7.4 • n=7 Participants
|
50 years
STANDARD_DEVIATION 8.2 • n=5 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
16 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
27 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
African American
|
15 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
31 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
6 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
More than one race
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Cigarettes per day
|
12.1 cigarettes smoked per day
STANDARD_DEVIATION 3.3 • n=5 Participants
|
16.6 cigarettes smoked per day
STANDARD_DEVIATION 8.4 • n=7 Participants
|
14.3 cigarettes smoked per day
STANDARD_DEVIATION 6.7 • n=5 Participants
|
|
Education
HS/GED or less
|
9 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
22 Participants
n=5 Participants
|
|
Education
Some college or more
|
13 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
21 Participants
n=5 Participants
|
|
Income
< $20,000
|
16 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
29 Participants
n=5 Participants
|
|
Income
> $20,000
|
6 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Week 2 and Week 6The quit assessment will begin the Monday morning of each quit week and will end that Friday. The total number of days of abstinence will be assessed.
Outcome measures
| Measure |
Ramelteon
n=43 Participants
Participants received 8mg of Ramelteon once per day + transdermal nicotine for 1 week.
|
Placebo
n=43 Participants
Participants received Placebo pills (matching Ramelteon 8mg pills) once per day + transdermal nicotine for 1 week.
|
Ramelteon (Quit Week)
Participants received 8mg of Ramelteon once per day + transdermal nicotine for 1 week.
|
Placebo (Quit Week)
Participants received Placebo pills (matching Ramelteon 8mg pills) once per day + transdermal nicotine for 1 week.
|
|---|---|---|---|---|
|
Total Number of Smoke-free Days (Biochemically Verified) During Each 5-day Quit Assessment.
|
2.7 days of smoking abstinence
Standard Deviation 1.6
|
2.6 days of smoking abstinence
Standard Deviation 1.6
|
—
|
—
|
SECONDARY outcome
Timeframe: Week 2 and Week 6Sleep onset latency will be assessed via daily sleep diaries during each quit assessment.
Outcome measures
| Measure |
Ramelteon
n=43 Participants
Participants received 8mg of Ramelteon once per day + transdermal nicotine for 1 week.
|
Placebo
n=43 Participants
Participants received Placebo pills (matching Ramelteon 8mg pills) once per day + transdermal nicotine for 1 week.
|
Ramelteon (Quit Week)
Participants received 8mg of Ramelteon once per day + transdermal nicotine for 1 week.
|
Placebo (Quit Week)
Participants received Placebo pills (matching Ramelteon 8mg pills) once per day + transdermal nicotine for 1 week.
|
|---|---|---|---|---|
|
Subjective Sleep Disturbance
|
20.8 minutes
Standard Deviation 12.7
|
23.7 minutes
Standard Deviation 23.9
|
—
|
—
|
SECONDARY outcome
Timeframe: Week 2 and Week 6Sleep efficiency (% of time in bed spent sleeping) will be assessed via the SensewearPro armbands during each quit assessment.
Outcome measures
| Measure |
Ramelteon
n=43 Participants
Participants received 8mg of Ramelteon once per day + transdermal nicotine for 1 week.
|
Placebo
n=43 Participants
Participants received Placebo pills (matching Ramelteon 8mg pills) once per day + transdermal nicotine for 1 week.
|
Ramelteon (Quit Week)
Participants received 8mg of Ramelteon once per day + transdermal nicotine for 1 week.
|
Placebo (Quit Week)
Participants received Placebo pills (matching Ramelteon 8mg pills) once per day + transdermal nicotine for 1 week.
|
|---|---|---|---|---|
|
Objective Sleep Disturbance
|
86.7 % of time in bed spent sleeping
Standard Deviation 12.5
|
86.6 % of time in bed spent sleeping
Standard Deviation 12.5
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline (weeks 1 and 5); Quit assessments (weeks 2 and 6)Side effects will be assessed at each in-person visit using a Side Effects Checklist (SEC) that lists 21 possible side effects of ramelteon. The scale for rating each side effect is None=0, Mild=1, Moderate=2, and Severe=3. The higher the score, the more side effects reported by the participant. The minimum score is 0 and the maximum score is 3 for each possible item on the scale. The Outcome Measure is an average of the 21 listed side effects.
Outcome measures
| Measure |
Ramelteon
n=43 Participants
Participants received 8mg of Ramelteon once per day + transdermal nicotine for 1 week.
|
Placebo
n=43 Participants
Participants received Placebo pills (matching Ramelteon 8mg pills) once per day + transdermal nicotine for 1 week.
|
Ramelteon (Quit Week)
n=43 Participants
Participants received 8mg of Ramelteon once per day + transdermal nicotine for 1 week.
|
Placebo (Quit Week)
n=43 Participants
Participants received Placebo pills (matching Ramelteon 8mg pills) once per day + transdermal nicotine for 1 week.
|
|---|---|---|---|---|
|
Side Effects of Ramelteon
|
0.028 scores on a scale
Standard Deviation 0.057
|
0.034 scores on a scale
Standard Deviation 0.047
|
0.05 scores on a scale
Standard Deviation 0.078
|
0.027 scores on a scale
Standard Deviation 0.041
|
Adverse Events
Ramelteon
Serious events: 0 serious events
Other events: 22 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 21 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Ramelteon
n=58 participants at risk
Participants received medication (8mg of Ramelteon) once per day + transdermal nicotine for 1 week.
|
Placebo
n=57 participants at risk
Participants received Placebo once per day + transdermal nicotine for 1 week.
|
|---|---|---|
|
Nervous system disorders
Headache
|
19.0%
11/58 • Number of events 21 • Through study completion, an average of 7 weeks
|
21.1%
12/57 • Number of events 20 • Through study completion, an average of 7 weeks
|
|
General disorders
Insomnia/Trouble Sleeping
|
20.7%
12/58 • Number of events 34 • Through study completion, an average of 7 weeks
|
15.8%
9/57 • Number of events 14 • Through study completion, an average of 7 weeks
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place