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Trial record 7 of 48 for:    Lorcaserin

Combination Nicotine Patch / Lorcaserin for Smoking Cessation (LorNic)

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ClinicalTrials.gov Identifier: NCT02906644
Recruitment Status : Completed
First Posted : September 20, 2016
Results First Posted : May 7, 2019
Last Update Posted : May 7, 2019
Sponsor:
Collaborator:
National Institute on Drug Abuse (NIDA)
Information provided by (Responsible Party):
Duke University

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Care Provider);   Primary Purpose: Treatment
Condition Nicotine Dependence
Interventions Drug: lorcaserin
Drug: nicotine patch
Drug: placebo lorcaserin
Enrollment 97
Recruitment Details Recruitment began on 11/8/2016 and ended on 2/20/2018. Of the 97 subjects (subjs.) consented during this period, 61 subjects met all study criteria, attended the first study visit, were randomized and received study intervention.
Pre-assignment Details Of the 97 subjs. enrolled, 36 were withdrawn by study staff or withdrew voluntarily from further participation prior to the 1st study visit (V1): 14 did not meet inclusion criteria, 16 met exclusion criteria, 3 were unable to meet study requirements, 2 were excluded due to laboratory values, and 1 was excluded by the medical staff.
Arm/Group Title Lorcaserin + Patch Patch
Hide Arm/Group Description

Participants will receive lorcaserin (10mg twice a day) and nicotine patches (21mg/24hr) for 14 weeks, at which point the nicotine patch dosage will be reduced to 14mg/24hr for 1 week, followed by 7mg/24hr for 1 week.

lorcaserin

nicotine patch

Participants will receive nicotine patches (21mg/24hr) and placebo lorcaserin for 2 weeks; after 2 weeks participants will begin to receive active lorcaserin (10mg twice a day) along with the nicotine patches for 12 weeks, at which point the nicotine patch dosage will be reduced to 14mg/24hr for 1 week, followed by 7mg/24hr for 1 week.

lorcaserin

nicotine patch

placebo lorcaserin

Period Title: First 2 Weeks
Started 31 30
Completed 30 27
Not Completed 1 3
Reason Not Completed
Withdrawal by Subject             0             2
Physician Decision             1             1
Period Title: Weeks 3 to 14
Started 30 [1] 27 [1]
Final Study Visit 17 [2] 20 [2]
Follow-up (6 Months Post Quit Day) 14 16
Completed 14 16
Not Completed 16 11
Reason Not Completed
Withdrawal by Subject             13             7
Lost to Follow-up             3             4
[1]
All participants receiving active Lorcaserin plus nicotine patches starting at the 2nd study visit.
[2]
All participants receiving only 1 week of 14mg & 1 week of 7mg nicotine patches at this visit.
Arm/Group Title Lorcaserin + Patch Patch Total
Hide Arm/Group Description

Participants will receive lorcaserin (10mg twice a day) and nicotine patches (21mg/24hr) for 14 weeks, at which point the nicotine patch dosage will be reduced to 14mg/24hr for 1 week, followed by 7mg/24hr for 1 week.

lorcaserin

nicotine patch

Participants will receive nicotine patches (21mg/24hr) and placebo lorcaserin for 2 weeks; after 2 weeks participants will begin to receive active lorcaserin (10mg twice a day) along with the nicotine patches for 12 weeks, at which point the nicotine patch dosage will be reduced to 14mg/24hr for 1 week, followed by 7mg/24hr for 1 week.

lorcaserin

nicotine patch

placebo lorcaserin

Total of all reporting groups
Overall Number of Baseline Participants 31 30 61
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Full Range)
Unit of measure:  Years
Number Analyzed 31 participants 30 participants 61 participants
47
(27 to 65)
50
(26 to 68)
49
(26 to 68)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 31 participants 30 participants 61 participants
Female
24
  77.4%
22
  73.3%
46
  75.4%
Male
7
  22.6%
8
  26.7%
15
  24.6%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 31 participants 30 participants 61 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
0
   0.0%
0
   0.0%
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
12
  38.7%
8
  26.7%
20
  32.8%
White
19
  61.3%
21
  70.0%
40
  65.6%
More than one race
0
   0.0%
1
   3.3%
1
   1.6%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
United States Number Analyzed 31 participants 30 participants 61 participants
31
 100.0%
30
 100.0%
61
 100.0%
1.Primary Outcome
Title Time-to-lapse
Hide Description Two weeks after treatment is initiated, with nicotine patch + lorcaserin or nicotine patch alone, but still two weeks prior to the quit day, subjects will be evaluated in a modified version of the McKee Smoking Lapse Task. In this task smokers, who have been abstinent for 2 hours will be provided with the option to smoke at any time, but paid by the minute for remaining abstinent with progressively decreasing payments over an hour.
Time Frame Week 2 pre quit day
Hide Outcome Measure Data
Hide Analysis Population Description
Four participants dropped out of the study and 3 more reported having already quit smoking before the Smoking Lapse Task occurred; therefore, we have lapse data for only 54 participants rather than 61.
Arm/Group Title Lorcaserin + Patch Patch
Hide Arm/Group Description:

Participants will receive lorcaserin (10mg twice a day) and nicotine patches (21mg/24hr) for 14 weeks, at which point the nicotine patch dosage will be reduced to 14mg/24hr for 1 week, followed by 7mg/24hr for 1 week.

lorcaserin

nicotine patch

Participants will receive nicotine patches (21mg/24hr) and placebo lorcaserin for 2 weeks; after 2 weeks participants will begin to receive active lorcaserin (10mg twice a day) along with the nicotine patches for 12 weeks, at which point the nicotine patch dosage will be reduced to 14mg/24hr for 1 week, followed by 7mg/24hr for 1 week.

lorcaserin

nicotine patch

placebo lorcaserin

Overall Number of Participants Analyzed 29 25
Mean (Standard Deviation)
Unit of Measure: Minutes
51.97  (18.331) 56.44  (12.490)
2.Primary Outcome
Title Smoking Withdrawal
Hide Description At the study visit above (two week post treatment initiation but 2 weeks prior to quit day), withdrawal symptoms will be assessed after 2 hours of smoking abstinence using the Shiffman-Jarvik (short form) questionnaire, which consists of 9 items rated from 1 to 7, where 1= not at all, 2= very little, 3= a little, 4= moderately, 5= a lot, 6= quite a lot, and 7= extremely. The 9 items are grouped into 8 subscales: Craving, Negative Affect, Appetite, and Arousal. The range of scores for each subscale will be 1-7, with higher scores indicating more of the withdrawal symptom having been experienced.
Time Frame Week 2 pre quit day
Hide Outcome Measure Data
Hide Analysis Population Description
Four participants dropped out of the study, 3 more reported having already quit smoking before the Smoking Lapse Task occurred, and 1 did not complete the withdrawal questionnaire; therefore, we have lapse data for only 53 participants rather than 61.
Arm/Group Title Lorcaserin + Patch Patch
Hide Arm/Group Description:

Participants will receive lorcaserin (10mg twice a day) and nicotine patches (21mg/24hr) for 14 weeks, at which point the nicotine patch dosage will be reduced to 14mg/24hr for 1 week, followed by 7mg/24hr for 1 week.

lorcaserin

nicotine patch

Participants will receive nicotine patches (21mg/24hr) and placebo lorcaserin for 2 weeks; after 2 weeks participants will begin to receive active lorcaserin (10mg twice a day) along with the nicotine patches for 12 weeks, at which point the nicotine patch dosage will be reduced to 14mg/24hr for 1 week, followed by 7mg/24hr for 1 week.

lorcaserin

nicotine patch

placebo lorcaserin

Overall Number of Participants Analyzed 28 25
Mean (Standard Deviation)
Unit of Measure: score on a scale
Craving 2.81  (1.271) 2.91  (1.219)
Negative Affect 2.15  (0.788) 2.21  (0.937)
Arousal 4.73  (1.014) 4.72  (1.251)
Appetite 3.11  (1.685) 2.80  (1.607)
3.Secondary Outcome
Title Number of Participants Reporting Smoking Abstinence
Hide Description Number of participants who reported continuous four-week abstinence from smoking (weeks 7-10 post target quit date), confirmed by expired air carbon monoxide (CO).
Time Frame Weeks 7-10 post quit day
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Lorcaserin + Patch Patch
Hide Arm/Group Description:

Participants will receive lorcaserin (10mg twice a day) and nicotine patches (21mg/24hr) for 14 weeks, at which point the nicotine patch dosage will be reduced to 14mg/24hr for 1 week, followed by 7mg/24hr for 1 week.

lorcaserin

nicotine patch

Participants will receive nicotine patches (21mg/24hr) and placebo lorcaserin for 2 weeks; after 2 weeks participants will begin to receive active lorcaserin (10mg twice a day) along with the nicotine patches for 12 weeks, at which point the nicotine patch dosage will be reduced to 14mg/24hr for 1 week, followed by 7mg/24hr for 1 week.

lorcaserin

nicotine patch

placebo lorcaserin

Overall Number of Participants Analyzed 31 30
Measure Type: Count of Participants
Unit of Measure: Participants
9
  29.0%
10
  33.3%
4.Secondary Outcome
Title Number of Participants Reporting Tolerability Issues With Lorcaserin + Nicotine Patch Treatment
Hide Description Tolerability of the lorcaserin + nicotine patch treatment will be assessed by tabulating the number of participants rating side effects > "moderate".
Time Frame Two Weeks pre and 10 weeks post quit day
Hide Outcome Measure Data
Hide Analysis Population Description
Two weeks pre-quit day, all study subjects were switched to taking active lorcaserin for the duration of the study. Twelve participants dropped out of the study prior to the next study visit, therefore side effects data from 2 weeks pre-quit to the end of the study are only available for 49 participants.
Arm/Group Title Lorcaserin + Nicotine Patch
Hide Arm/Group Description:
All participants received active lorcaserin plus nicotine patches starting at Study Visit 2 (two weeks from baseline and two weeks prior to their quit day) after 2 weeks of receiving either active or placebo lorcaserin along with the nicotine patches.
Overall Number of Participants Analyzed 49
Measure Type: Count of Participants
Unit of Measure: Participants
26
  53.1%
5.Secondary Outcome
Title Weight Gain Following Continuous Four-week Abstinence From Smoking
Hide Description Among smoking-abstinent participants, weight gain relative to baseline will be assessed.
Time Frame Week 10 post quit day
Hide Outcome Measure Data
Hide Analysis Population Description
Two weeks pre-quit day, all study subjects were switched to taking active lorcaserin for the duration of the study. Nineteen participants reported continuous four-week abstinence from smoking (weeks 7-10 post target quit date), confirmed by expired air carbon monoxide (CO).
Arm/Group Title Lorcaserin + Nicotine Patch
Hide Arm/Group Description:
All participants received active lorcaserin plus nicotine patches starting at Study Visit 2 (two weeks from baseline and two weeks prior to their quit day) after 2 weeks of receiving either active or placebo lorcaserin along with the nicotine patches.
Overall Number of Participants Analyzed 19
Mean (Standard Deviation)
Unit of Measure: weight gain (in lbs)
-0.35  (7.203)
6.Secondary Outcome
Title Number of Participants Reporting 6-month Smoking Abstinence
Hide Description Number of participants who reported not smoking for the previous seven days when called for 6-month follow-up, confirmed by expired air carbon monoxide (CO).
Time Frame 6 months post Quit Day
Hide Outcome Measure Data
Hide Analysis Population Description
Two weeks pre-quit day, all study subjects were switched to taking active lorcaserin for the duration of the study. Nine participants reported continuous 7-day abstinence from smoking 6 months post quit-day, confirmed by expired air carbon monoxide (CO).
Arm/Group Title Lorcaserin + Nicotine Patch
Hide Arm/Group Description:
All participants received active lorcaserin plus nicotine patches starting at Study Visit 2 (two weeks from baseline and two weeks prior to their quit day) after 2 weeks of receiving either active or placebo lorcaserin along with the nicotine patches.
Overall Number of Participants Analyzed 61
Measure Type: Count of Participants
Unit of Measure: Participants
9
  14.8%
7.Secondary Outcome
Title Percentage of Change in Ad Libitum Smoking at End of Week 2
Hide Description To evaluate the effects of lorcaserin on ad libitum (ad lib) smoking, the percent change in reported number of cigarettes smoked from baseline to the end of week 2 (the day prior to the 2nd study visit) will be calculated.
Time Frame Week 2 pre quit day
Hide Outcome Measure Data
Hide Analysis Population Description
There are insufficient data for 9 participants in the Lorcaserin + Patch group and for 8 participants in the Patch only group (due to participant dropout or incomplete or unreturned diaries) so this analysis excluded those individuals.
Arm/Group Title Lorcaserin + Patch Patch
Hide Arm/Group Description:

Participants will receive lorcaserin (10mg twice a day) and nicotine patches (21mg/24hr) for 14 weeks, at which point the nicotine patch dosage will be reduced to 14mg/24hr for 1 week, followed by 7mg/24hr for 1 week.

lorcaserin

nicotine patch

Participants will receive nicotine patches (21mg/24hr) and placebo lorcaserin for 2 weeks; after 2 weeks participants will begin to receive active lorcaserin (10mg twice a day) along with the nicotine patches for 12 weeks, at which point the nicotine patch dosage will be reduced to 14mg/24hr for 1 week, followed by 7mg/24hr for 1 week.

lorcaserin

nicotine patch

placebo lorcaserin

Overall Number of Participants Analyzed 22 22
Mean (Standard Deviation)
Unit of Measure: percentage of change
-35.58  (0.396) -47.13  (0.482)
8.Secondary Outcome
Title Adherence to Lorcaserin + Nicotine Patch Treatment as Indicator of Tolerability
Hide Description Tolerability of the lorcaserin + nicotine patch treatment will be assessed by calculating adherence scores based on the percentage of days on which the study drugs were taken between visits as reported by participants on diaries.
Time Frame Two Weeks pre and 10 weeks post quit day
Hide Outcome Measure Data
Hide Analysis Population Description
Two weeks pre-quit day, all study subjects were switched to taking active lorcaserin for the duration of the study. Fourteen subjects either dropped out prior to Visit 3 (the first visit after all subjects were on combined treatment) or had missing or incomplete diaries, so data are only available for 47 subjects during this phase of the study.
Arm/Group Title Lorcaserin + Nicotine Patch
Hide Arm/Group Description:
All participants received active lorcaserin plus nicotine patches starting at Study Visit 2 (two weeks from baseline and two weeks prior to their quit day) after 2 weeks of receiving either active or placebo lorcaserin along with the nicotine patches.
Overall Number of Participants Analyzed 47
Mean (Standard Deviation)
Unit of Measure: percentage of days using study drugs
72.15  (0.339)
Time Frame Subjects (subjs.) received (rcvd.) study drugs for 16 weeks. At each study session during this period subjs. completed a questionnaire (quest) about side effects (SE). Subjs. were also told to contact study staff between study sessions if SE were bothersome.
Adverse Event Reporting Description Serious Adverse Events (AE) and other AEs were evaluated for all subjs. who rcvd. nicotine patches and lorcaserin (31) or nicotine patches and placebo (30) at Visit (V) 1, & for all subjs. receiving nicotine patches and lorcaserin at V2 and subsequent visits (56) who completed side effects (SE) quest. Systematic evaluation of SE began at V2 after 2 weeks of study drug use (30 subjs. who had rcvd. nicotine patches and lorcaserin and 27 who had rcvd. nicotine patches and placebo).
 
Arm/Group Title Lorcaserin + Patch Patch (1st 2 Weeks)
Hide Arm/Group Description

Participants will receive lorcaserin (10mg twice a day) and nicotine patches (21mg/24hr) for 14 weeks, at which point the nicotine patch dosage will be reduced to 14mg/24hr for 1 week, followed by 7mg/24hr for 1 week. Group 1 will receive this combined treatment throughout the study; Group 2 will receive the combined treatment after the first 2 weeks of receiving the nicotine patch only (with placebo lorcaserin).

lorcaserin

nicotine patch

Participants will receive nicotine patches (21mg/24hr) and placebo lorcaserin for 2 weeks; after 2 weeks participants will begin to receive active lorcaserin (10mg twice a day) along with the nicotine patches for 12 weeks, at which point the nicotine patch dosage will be reduced to 14mg/24hr for 1 week, followed by 7mg/24hr for 1 week.

lorcaserin

nicotine patch

placebo lorcaserin

All-Cause Mortality
Lorcaserin + Patch Patch (1st 2 Weeks)
Affected / at Risk (%) Affected / at Risk (%)
Total   0/56 (0.00%)      0/27 (0.00%)    
Show Serious Adverse Events Hide Serious Adverse Events
Lorcaserin + Patch Patch (1st 2 Weeks)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/56 (0.00%)      1/27 (3.70%)    
General disorders     
Somnambulism *  0/56 (0.00%)  0 1/27 (3.70%)  1
*
Indicates events were collected by non-systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Lorcaserin + Patch Patch (1st 2 Weeks)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   35/56 (62.50%)      12/27 (44.44%)    
Gastrointestinal disorders     
Nausea   3/56 (5.36%)  3 0/27 (0.00%)  0
Constipation   5/56 (8.93%)  9 0/27 (0.00%)  0
General disorders     
Fatigue   12/56 (21.43%)  14 2/27 (7.41%)  2
Dizziness/Lightheadedness   3/56 (5.36%)  3 0/27 (0.00%)  0
Insomnia   4/56 (7.14%)  5 1/27 (3.70%)  1
Vivid Dreams   20/56 (35.71%)  27 9/27 (33.33%)  9
Dry Mouth   7/56 (12.50%)  13 0/27 (0.00%)  0
Coughing   5/56 (8.93%)  8 2/27 (7.41%)  2
Skin and subcutaneous tissue disorders     
Itching at Patch Site   13/56 (23.21%)  25 4/27 (14.81%)  4
Rash at Patch Site   5/56 (8.93%)  11 0/27 (0.00%)  0
Indicates events were collected by systematic assessment
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Clinical Research Coordinator
Organization: Duke University
Phone: (919) 668-5055
EMail: al.salley@duke.edu
Layout table for additonal information
Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT02906644     History of Changes
Other Study ID Numbers: Pro00074741
P50DA027840-06 ( U.S. NIH Grant/Contract )
First Submitted: September 15, 2016
First Posted: September 20, 2016
Results First Submitted: March 1, 2019
Results First Posted: May 7, 2019
Last Update Posted: May 7, 2019