Nicotine Dependence, Smoking
Conditions
Keywords
Tobacco, Smoking, Weight, Weight perception, Naltrexone, Bupropion
Brief summary
This study will test a combination of the drugs naltrexone and bupropion with weight-concerned smokers to investigate whether or not this combination of drugs improves smoking cessation quit rates and minimizes post quit weight gain.
Detailed description
This is an open label smoking cessation clinical trial of 25 mg naltrexone with 300 mg bupropion sustained-release (SR) in six male and fourteen female participants. This pilot study is being conducted to determine: * effect size estimates for smoking cessation and post-cessation weight gain, which will be used to compute the sample size needed for a large-scale clinical trial; and * compliance with a combination of 25 mg naltrexone and 300 mg bupropion SR. In addition to examining the sample in this study, the investigators plan to compare this sample to a sample of matched controls.
Interventions
DRUGNaltrexone
Participants received naltrexone hydrochloride on the sixth day of bupropion treatment, and the initial dose was 12.5 mg, followed by 25 mg daily for the duration of the 7-week treatment.
DRUGBupropion
Starting with the baseline visit, all participants received 150 mg of bupropion SR once per day for 3 days, then twice per day for the duration of the 7-week treatment period.
Sponsors
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Yale University
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Ages 18 and older * Willingness and ability to give written consent * Smoking at least 10 cigarettes per day for at least 1 year * Baseline expired carbon-monoxide level of at least 10 ppm * Weigh at least 100 lbs. * English-speaking * One person per household * At least 1 prior quit attempt * Concern about gaining weight. This will be assessed using a questionnaire that will provide a rating system to determine qualified participants.
Exclusion criteria
* Pregnant or nursing women or women attempting to conceive * Serious current neurologic, psychiatric or medical illness, including unstable cardiac, hepatic, or renal disease and diabetes and hypertension * Current alcohol dependence * Current use of opiates, and/or a urine toxicology screen positive for opiates * Chronic pain conditions necessitating opioid treatment (naltrexone, an opioid antagonist will make these medications ineffective) * Evidence of significant hepatocellular injury as evidenced by AST or ALT \>3 x normal or elevated bilirubin * History of cirrhosis * Body mass index (BMI) greater than 35 * History of anorexia nervosa or bulimia * Current major depression * Currently taking Toprol-XL (or metoprolol succinate) * History of seizure disorder or serious brain injury * Current use of smokeless tobacco, pipes, cigars, nicotine gum, nicotine patch, nicotine inhaler, nicotine lozenge, nicotine nasal spray, or bupropion * Previous hypersensitivity to bupropion * Patients requiring concomitant therapy with any psychotropic drug * Participation in the Framing Messages for Smoking Cessation With Bupropion study (HIC#: 10880)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Smoking Cessation | Week 6 | Smoking cessation is defined as the number of patients that displayed continuous 6-week abstinence from the quit date. |
| Point Prevalence Abstinence | Week 6 | Point prevalence abstinence is defined as the number of patients reporting point prevalence abstinence over the last 7 days. |
| Weight Gain | Week 6 | Weight gain for for the entire sample in pounds at 6 weeks. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Weight Gain Abstinent Participants | Week 6 | Weight gain (in pounds) for the patients that were continuously abstinent at 6 weeks. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Bupropion Only The placebo comparator was a group of matched controls who received an identical psychosocial intervention and bupropion SR treatment regimen in a similar 7-week study investigation compared to naltrexone hydrochloride (25 mg/day) in combination with bupropion hydrochloride SR (300 mg/day).
Bupropion : Starting with the baseline visit, all participants received 150 mg of bupropion SR once per day for 3 days, then twice per day for the duration of the 7-week treatment period. | 20 |
| Naltrexone +Bupropion The active comparator in this 7-week open label study investigation was naltrexone hydrochloride (25 mg/day) in combination with bupropion hydrochloride SR (300 mg/day) compared to matched controls who received an identical psychosocial intervention and bupropion SR treatment regimen (bupropion only).
Naltrexone : Participants received naltrexone hydrochloride on the sixth day of bupropion treatment, and the initial dose was 12.5 mg, followed by 25 mg daily for the duration of the 7-week treatment.
Bupropion : Starting with the baseline visit, all participants received 150 mg of bupropion SR once per day for 3 days, then twice per day for the duration of the 7-week treatment period. | 20 |
| Total | 40 |
Baseline characteristics
| Characteristic | Bupropion Only | Naltrexone +Bupropion | Total |
|---|---|---|---|
| Age, Continuous | 42.3 years STANDARD_DEVIATION 12.3 | 43.0 years STANDARD_DEVIATION 11.2 | 42.7 years STANDARD_DEVIATION 11.6 |
| Sex: Female, Male Female | 14 Participants | 14 Participants | 28 Participants |
| Sex: Female, Male Male | 6 Participants | 6 Participants | 12 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 8 / 20 | 9 / 20 |
| serious Total, serious adverse events | 0 / 20 | 0 / 20 |
Outcome results
Primary
Point Prevalence Abstinence
Point prevalence abstinence is defined as the number of patients reporting point prevalence abstinence over the last 7 days.
Time frame: Week 6
Population: Per protocol analysis
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Bupropion Only | Point Prevalence Abstinence | 8 participants |
| Naltrexone +Bupropion | Point Prevalence Abstinence | 8 participants |
Primary
Smoking Cessation
Smoking cessation is defined as the number of patients that displayed continuous 6-week abstinence from the quit date.
Time frame: Week 6
Population: Per protocol analysis
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Bupropion Only | Smoking Cessation | 6 participants |
| Naltrexone +Bupropion | Smoking Cessation | 6 participants |
Primary
Weight Gain
Weight gain for for the entire sample in pounds at 6 weeks.
Time frame: Week 6
Population: Per protocol analysis
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Bupropion Only | Weight Gain | 1.25 lbs | Standard Deviation 2.9 |
| Naltrexone +Bupropion | Weight Gain | 0.28 lbs | Standard Deviation 3.88 |
Secondary
Weight Gain Abstinent Participants
Weight gain (in pounds) for the patients that were continuously abstinent at 6 weeks.
Time frame: Week 6
Population: Per protocol analysis
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Bupropion Only | Weight Gain Abstinent Participants | 3.17 lbs | Standard Deviation 2.04 |
| Naltrexone +Bupropion | Weight Gain Abstinent Participants | 1.67 lbs | Standard Deviation 3.17 |