Trial Outcomes & Findings for Targeted Interventions for Weight-Concerned Smokers (NCT NCT00105482)
NCT ID: NCT00105482
Last Updated: 2013-03-05
Results Overview
Weight change from baseline measured at 26 weeks.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
172 participants
Primary outcome timeframe
26 weeks
Results posted on
2013-03-05
Participant Flow
Participant milestones
| Measure |
Naltrexone
Arm 1 (Experimental) = Transdermal nicotine replacement (21 mg for first 6 weeks post-quit then 14 mg for 2 weeks) once per day + Naltrexone 25 mg oral capsule once per day
Transdermal nicotine replacement : Transdermal nicotine replacement (21 mg for first 6 weeks post-quit then 14 mg for 2 weeks) once per day + naltrexone 25 mg oral capsule once per day
Naltrexone : Drug: Naltrexone 12.5 mg oral capsule once per day for 1 day then 25 mg oral capsule once per day for 27 weeks
Behavioral counseling : Brief behavioral counseling and research assessments are provided for two sessions prior to the quit date and then weekly for two weeks, bi-weekly for a month and every four weeks thereafter.
|
Placebo
Arm 2 (Placebo Comparator) = Transdermal nicotine replacement (21 mg for first 6 weeks post-quit then 14 mg for 2 weeks) once per day + Placebo Naltrexone 25 mg oral capsule once per day
Behavioral counseling : Brief behavioral counseling and research assessments are provided for two sessions prior to the quit date and then weekly for two weeks, bi-weekly for a month and every four weeks thereafter.
|
|---|---|---|
|
Overall Study
STARTED
|
87
|
85
|
|
Overall Study
COMPLETED
|
28
|
30
|
|
Overall Study
NOT COMPLETED
|
59
|
55
|
Reasons for withdrawal
| Measure |
Naltrexone
Arm 1 (Experimental) = Transdermal nicotine replacement (21 mg for first 6 weeks post-quit then 14 mg for 2 weeks) once per day + Naltrexone 25 mg oral capsule once per day
Transdermal nicotine replacement : Transdermal nicotine replacement (21 mg for first 6 weeks post-quit then 14 mg for 2 weeks) once per day + naltrexone 25 mg oral capsule once per day
Naltrexone : Drug: Naltrexone 12.5 mg oral capsule once per day for 1 day then 25 mg oral capsule once per day for 27 weeks
Behavioral counseling : Brief behavioral counseling and research assessments are provided for two sessions prior to the quit date and then weekly for two weeks, bi-weekly for a month and every four weeks thereafter.
|
Placebo
Arm 2 (Placebo Comparator) = Transdermal nicotine replacement (21 mg for first 6 weeks post-quit then 14 mg for 2 weeks) once per day + Placebo Naltrexone 25 mg oral capsule once per day
Behavioral counseling : Brief behavioral counseling and research assessments are provided for two sessions prior to the quit date and then weekly for two weeks, bi-weekly for a month and every four weeks thereafter.
|
|---|---|---|
|
Overall Study
Adverse Event
|
1
|
1
|
|
Overall Study
Lost to Follow-up
|
26
|
17
|
|
Overall Study
Withdrawal by Subject
|
0
|
1
|
|
Overall Study
Lost Interest
|
29
|
32
|
|
Overall Study
Scheduling Conflict
|
2
|
3
|
|
Overall Study
Withdrawn by PI
|
1
|
1
|
Baseline Characteristics
Targeted Interventions for Weight-Concerned Smokers
Baseline characteristics by cohort
| Measure |
Naltrexone
n=87 Participants
Arm 1 (Experimental) = Transdermal nicotine replacement (21 mg for first 6 weeks post-quit then 14 mg for 2 weeks) once per day + Naltrexone 25 mg oral capsule once per day
Transdermal nicotine replacement : Transdermal nicotine replacement (21 mg for first 6 weeks post-quit then 14 mg for 2 weeks) once per day + naltrexone 25 mg oral capsule once per day
Naltrexone : Drug: Naltrexone 12.5 mg oral capsule once per day for 1 day then 25 mg oral capsule once per day for 27 weeks
Behavioral counseling : Brief behavioral counseling and research assessments are provided for two sessions prior to the quit date and then weekly for two weeks, bi-weekly for a month and every four weeks thereafter.
|
Placebo
n=85 Participants
Arm 2 (Placebo Comparator) = Transdermal nicotine replacement (21 mg for first 6 weeks post-quit then 14 mg for 2 weeks) once per day + Placebo Naltrexone 25 mg oral capsule once per day
Behavioral counseling : Brief behavioral counseling and research assessments are provided for two sessions prior to the quit date and then weekly for two weeks, bi-weekly for a month and every four weeks thereafter.
|
Total
n=172 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age Continuous
|
43.2 years
STANDARD_DEVIATION 10.0 • n=5 Participants
|
45.5 years
STANDARD_DEVIATION 11.3 • n=7 Participants
|
44.4 years
STANDARD_DEVIATION 10.7 • n=5 Participants
|
|
Sex: Female, Male
Female
|
62 Participants
n=5 Participants
|
61 Participants
n=7 Participants
|
123 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
25 Participants
n=5 Participants
|
24 Participants
n=7 Participants
|
49 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 26 weeksPopulation: All patients who were randomized comprised the primary ITT population.
Weight change from baseline measured at 26 weeks.
Outcome measures
| Measure |
Naltrexone
n=87 Participants
Arm 1 (Experimental) = Transdermal nicotine replacement (21 mg for first 6 weeks post-quit then 14 mg for 2 weeks) once per day + Naltrexone 25 mg oral capsule once per day
Transdermal nicotine replacement : Transdermal nicotine replacement (21 mg for first 6 weeks post-quit then 14 mg for 2 weeks) once per day + naltrexone 25 mg oral capsule once per day
Naltrexone : Drug: Naltrexone 12.5 mg oral capsule once per day for 1 day then 25 mg oral capsule once per day for 27 weeks
Behavioral counseling : Brief behavioral counseling and research assessments are provided for two sessions prior to the quit date and then weekly for two weeks, bi-weekly for a month and every four weeks thereafter.
|
Placebo
n=85 Participants
Arm 2 (Placebo Comparator) = Transdermal nicotine replacement (21 mg for first 6 weeks post-quit then 14 mg for 2 weeks) once per day + Placebo Naltrexone 25 mg oral capsule once per day
Behavioral counseling : Brief behavioral counseling and research assessments are provided for two sessions prior to the quit date and then weekly for two weeks, bi-weekly for a month and every four weeks thereafter.
|
|---|---|---|
|
Weight Gain at 26 Weeks.
|
6.75 pounds
Standard Deviation 8.94
|
9.71 pounds
Standard Deviation 9.19
|
PRIMARY outcome
Timeframe: 26 weeksPopulation: All patients who were randomized comprised the primary ITT population.
The number of people that were abstinent from cigarette smoking at 26 weeks.
Outcome measures
| Measure |
Naltrexone
n=87 Participants
Arm 1 (Experimental) = Transdermal nicotine replacement (21 mg for first 6 weeks post-quit then 14 mg for 2 weeks) once per day + Naltrexone 25 mg oral capsule once per day
Transdermal nicotine replacement : Transdermal nicotine replacement (21 mg for first 6 weeks post-quit then 14 mg for 2 weeks) once per day + naltrexone 25 mg oral capsule once per day
Naltrexone : Drug: Naltrexone 12.5 mg oral capsule once per day for 1 day then 25 mg oral capsule once per day for 27 weeks
Behavioral counseling : Brief behavioral counseling and research assessments are provided for two sessions prior to the quit date and then weekly for two weeks, bi-weekly for a month and every four weeks thereafter.
|
Placebo
n=85 Participants
Arm 2 (Placebo Comparator) = Transdermal nicotine replacement (21 mg for first 6 weeks post-quit then 14 mg for 2 weeks) once per day + Placebo Naltrexone 25 mg oral capsule once per day
Behavioral counseling : Brief behavioral counseling and research assessments are provided for two sessions prior to the quit date and then weekly for two weeks, bi-weekly for a month and every four weeks thereafter.
|
|---|---|---|
|
Point Prevalence Smoking Abstinence at 26 Weeks.
|
19 participants
|
23 participants
|
SECONDARY outcome
Timeframe: 6 weeksPopulation: All patients who were randomized comprised the primary ITT population.
Weight change from baseline measured at 6 weeks.
Outcome measures
| Measure |
Naltrexone
n=87 Participants
Arm 1 (Experimental) = Transdermal nicotine replacement (21 mg for first 6 weeks post-quit then 14 mg for 2 weeks) once per day + Naltrexone 25 mg oral capsule once per day
Transdermal nicotine replacement : Transdermal nicotine replacement (21 mg for first 6 weeks post-quit then 14 mg for 2 weeks) once per day + naltrexone 25 mg oral capsule once per day
Naltrexone : Drug: Naltrexone 12.5 mg oral capsule once per day for 1 day then 25 mg oral capsule once per day for 27 weeks
Behavioral counseling : Brief behavioral counseling and research assessments are provided for two sessions prior to the quit date and then weekly for two weeks, bi-weekly for a month and every four weeks thereafter.
|
Placebo
n=85 Participants
Arm 2 (Placebo Comparator) = Transdermal nicotine replacement (21 mg for first 6 weeks post-quit then 14 mg for 2 weeks) once per day + Placebo Naltrexone 25 mg oral capsule once per day
Behavioral counseling : Brief behavioral counseling and research assessments are provided for two sessions prior to the quit date and then weekly for two weeks, bi-weekly for a month and every four weeks thereafter.
|
|---|---|---|
|
Weight Gain at 6 Weeks.
|
2.53 pounds
Standard Deviation 4.58
|
2.19 pounds
Standard Deviation 4.20
|
SECONDARY outcome
Timeframe: 6 weeksPopulation: All patients who were randomized comprised the primary ITT population.
The number of people that were abstinent from cigarette smoking at 6 weeks.
Outcome measures
| Measure |
Naltrexone
n=87 Participants
Arm 1 (Experimental) = Transdermal nicotine replacement (21 mg for first 6 weeks post-quit then 14 mg for 2 weeks) once per day + Naltrexone 25 mg oral capsule once per day
Transdermal nicotine replacement : Transdermal nicotine replacement (21 mg for first 6 weeks post-quit then 14 mg for 2 weeks) once per day + naltrexone 25 mg oral capsule once per day
Naltrexone : Drug: Naltrexone 12.5 mg oral capsule once per day for 1 day then 25 mg oral capsule once per day for 27 weeks
Behavioral counseling : Brief behavioral counseling and research assessments are provided for two sessions prior to the quit date and then weekly for two weeks, bi-weekly for a month and every four weeks thereafter.
|
Placebo
n=85 Participants
Arm 2 (Placebo Comparator) = Transdermal nicotine replacement (21 mg for first 6 weeks post-quit then 14 mg for 2 weeks) once per day + Placebo Naltrexone 25 mg oral capsule once per day
Behavioral counseling : Brief behavioral counseling and research assessments are provided for two sessions prior to the quit date and then weekly for two weeks, bi-weekly for a month and every four weeks thereafter.
|
|---|---|---|
|
Point Prevalence Smoking Abstinence at 6 Weeks
|
33 participants
|
43 participants
|
SECONDARY outcome
Timeframe: 26 weeksPopulation: Patients were analyzed per protocol.
Average number of cigarettes smoked per day at 26 weeks.
Outcome measures
| Measure |
Naltrexone
n=67 Participants
Arm 1 (Experimental) = Transdermal nicotine replacement (21 mg for first 6 weeks post-quit then 14 mg for 2 weeks) once per day + Naltrexone 25 mg oral capsule once per day
Transdermal nicotine replacement : Transdermal nicotine replacement (21 mg for first 6 weeks post-quit then 14 mg for 2 weeks) once per day + naltrexone 25 mg oral capsule once per day
Naltrexone : Drug: Naltrexone 12.5 mg oral capsule once per day for 1 day then 25 mg oral capsule once per day for 27 weeks
Behavioral counseling : Brief behavioral counseling and research assessments are provided for two sessions prior to the quit date and then weekly for two weeks, bi-weekly for a month and every four weeks thereafter.
|
Placebo
n=67 Participants
Arm 2 (Placebo Comparator) = Transdermal nicotine replacement (21 mg for first 6 weeks post-quit then 14 mg for 2 weeks) once per day + Placebo Naltrexone 25 mg oral capsule once per day
Behavioral counseling : Brief behavioral counseling and research assessments are provided for two sessions prior to the quit date and then weekly for two weeks, bi-weekly for a month and every four weeks thereafter.
|
|---|---|---|
|
Cigarettes Smoked Per Day.
|
7.10 number of cigarettes
Standard Deviation 8.43
|
7.85 number of cigarettes
Standard Deviation 8.35
|
Adverse Events
Naltrexone
Serious events: 2 serious events
Other events: 51 other events
Deaths: 0 deaths
Placebo
Serious events: 2 serious events
Other events: 51 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Naltrexone
n=87 participants at risk
Arm 1 (Experimental) = Transdermal nicotine replacement (21 mg for first 6 weeks post-quit then 14 mg for 2 weeks) once per day + Naltrexone 25 mg oral capsule once per day
Transdermal nicotine replacement : Transdermal nicotine replacement (21 mg for first 6 weeks post-quit then 14 mg for 2 weeks) once per day + naltrexone 25 mg oral capsule once per day
Naltrexone : Drug: Naltrexone 12.5 mg oral capsule once per day for 1 day then 25 mg oral capsule once per day for 27 weeks
Behavioral counseling : Brief behavioral counseling and research assessments are provided for two sessions prior to the quit date and then weekly for two weeks, bi-weekly for a month and every four weeks thereafter.
|
Placebo
n=85 participants at risk
Arm 2 (Placebo Comparator) = Transdermal nicotine replacement (21 mg for first 6 weeks post-quit then 14 mg for 2 weeks) once per day + Placebo Naltrexone 25 mg oral capsule once per day
Behavioral counseling : Brief behavioral counseling and research assessments are provided for two sessions prior to the quit date and then weekly for two weeks, bi-weekly for a month and every four weeks thereafter.
|
|---|---|---|
|
Psychiatric disorders
Anxiety
|
1.1%
1/87 • Number of events 1 • 26 months
|
0.00%
0/85 • 26 months
|
|
Cardiac disorders
Abnormal EKG
|
1.1%
1/87 • Number of events 1 • 26 months
|
0.00%
0/85 • 26 months
|
|
General disorders
Finger Laceration
|
0.00%
0/87 • 26 months
|
1.2%
1/85 • Number of events 1 • 26 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Thyroid Cancer
|
0.00%
0/87 • 26 months
|
1.2%
1/85 • Number of events 1 • 26 months
|
Other adverse events
| Measure |
Naltrexone
n=87 participants at risk
Arm 1 (Experimental) = Transdermal nicotine replacement (21 mg for first 6 weeks post-quit then 14 mg for 2 weeks) once per day + Naltrexone 25 mg oral capsule once per day
Transdermal nicotine replacement : Transdermal nicotine replacement (21 mg for first 6 weeks post-quit then 14 mg for 2 weeks) once per day + naltrexone 25 mg oral capsule once per day
Naltrexone : Drug: Naltrexone 12.5 mg oral capsule once per day for 1 day then 25 mg oral capsule once per day for 27 weeks
Behavioral counseling : Brief behavioral counseling and research assessments are provided for two sessions prior to the quit date and then weekly for two weeks, bi-weekly for a month and every four weeks thereafter.
|
Placebo
n=85 participants at risk
Arm 2 (Placebo Comparator) = Transdermal nicotine replacement (21 mg for first 6 weeks post-quit then 14 mg for 2 weeks) once per day + Placebo Naltrexone 25 mg oral capsule once per day
Behavioral counseling : Brief behavioral counseling and research assessments are provided for two sessions prior to the quit date and then weekly for two weeks, bi-weekly for a month and every four weeks thereafter.
|
|---|---|---|
|
General disorders
Abdominal Pain
|
34.5%
30/87 • Number of events 30 • 26 months
|
28.2%
24/85 • Number of events 24 • 26 months
|
|
Psychiatric disorders
Anxiety
|
44.8%
39/87 • Number of events 39 • 26 months
|
41.2%
35/85 • Number of events 35 • 26 months
|
|
Eye disorders
Blurred Vision
|
11.5%
10/87 • Number of events 10 • 26 months
|
12.9%
11/85 • Number of events 11 • 26 months
|
|
Gastrointestinal disorders
Constipation
|
33.3%
29/87 • Number of events 29 • 26 months
|
32.9%
28/85 • Number of events 28 • 26 months
|
|
Metabolism and nutrition disorders
Decreased Appetite
|
49.4%
43/87 • Number of events 43 • 26 months
|
32.9%
28/85 • Number of events 28 • 26 months
|
|
Psychiatric disorders
Depression
|
31.0%
27/87 • Number of events 27 • 26 months
|
36.5%
31/85 • Number of events 31 • 26 months
|
|
Nervous system disorders
Dizziness
|
39.1%
34/87 • Number of events 34 • 26 months
|
29.4%
25/85 • Number of events 25 • 26 months
|
|
General disorders
Fatigue
|
50.6%
44/87 • Number of events 44 • 26 months
|
43.5%
37/85 • Number of events 37 • 26 months
|
|
Nervous system disorders
Headache
|
44.8%
39/87 • Number of events 39 • 26 months
|
42.4%
36/85 • Number of events 36 • 26 months
|
|
Metabolism and nutrition disorders
Increased Appetite
|
49.4%
43/87 • Number of events 43 • 26 months
|
42.4%
36/85 • Number of events 36 • 26 months
|
|
Gastrointestinal disorders
Increased Bowel Freq
|
12.6%
11/87 • Number of events 11 • 26 months
|
18.8%
16/85 • Number of events 16 • 26 months
|
|
General disorders
Insomnia
|
46.0%
40/87 • Number of events 40 • 26 months
|
43.5%
37/85 • Number of events 37 • 26 months
|
|
Skin and subcutaneous tissue disorders
Itching
|
35.6%
31/87 • Number of events 31 • 26 months
|
37.6%
32/85 • Number of events 32 • 26 months
|
|
General disorders
Change in Libido
|
16.1%
14/87 • Number of events 14 • 26 months
|
15.3%
13/85 • Number of events 13 • 26 months
|
|
Reproductive system and breast disorders
Missed Period
|
3.4%
3/87 • Number of events 3 • 26 months
|
2.4%
2/85 • Number of events 2 • 26 months
|
|
Musculoskeletal and connective tissue disorders
Muscle Weakness
|
11.5%
10/87 • Number of events 10 • 26 months
|
15.3%
13/85 • Number of events 13 • 26 months
|
|
Gastrointestinal disorders
Nausea
|
55.2%
48/87 • Number of events 48 • 26 months
|
29.4%
25/85 • Number of events 25 • 26 months
|
|
Cardiac disorders
Rapid Heartbeat
|
20.7%
18/87 • Number of events 18 • 26 months
|
22.4%
19/85 • Number of events 19 • 26 months
|
|
Skin and subcutaneous tissue disorders
Rash
|
27.6%
24/87 • Number of events 24 • 26 months
|
30.6%
26/85 • Number of events 26 • 26 months
|
|
General disorders
Sleepiness
|
37.9%
33/87 • Number of events 33 • 26 months
|
27.1%
23/85 • Number of events 23 • 26 months
|
|
Endocrine disorders
Sweating
|
46.0%
40/87 • Number of events 40 • 26 months
|
24.7%
21/85 • Number of events 21 • 26 months
|
|
Psychiatric disorders
Vivid Dreams
|
58.6%
51/87 • Number of events 51 • 26 months
|
60.0%
51/85 • Number of events 51 • 26 months
|
|
Gastrointestinal disorders
Vomiting
|
21.8%
19/87 • Number of events 19 • 26 months
|
4.7%
4/85 • Number of events 4 • 26 months
|
|
General disorders
Other
|
35.6%
31/87 • Number of events 31 • 26 months
|
32.9%
28/85 • Number of events 28 • 26 months
|
Additional Information
Stephanie Samples O'Malley PhD, Director, Division of Substance Abuse Research
Yale School of Medicine, Department of Psychiatry
Phone: (203) 974-7590
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place