Nicotine Dependence
Conditions
Keywords
addiction, smoking, tobacco, cigarettes
Brief summary
You are invited to participate in a research study at the VA Connecticut Healthcare System (West Haven campus) that examines whether a medication called galantamine can improve your learning and memory, and also help you to quit smoking. You have been invited to participate because you currently smoke cigarettes, and want to quit smoking. If you are eligible and agree to be in the study, your participation will last for approximately 8 weeks. To determine if galantamine (8 or 16 mg) is superior to placebo a) in reducing smoking self-administration in a human laboratory model and b) improving abstinence rates at the end of 4 weeks of treatment.
Detailed description
We propose a double-blind, placebo-controlled, outpatient study with a between-groups design. Seventy-two male and female smokers will be randomly assigned to one of the 3 treatment conditions: GAL (8 or 16 mg/day) or placebo. The dose of GAL will be gradually increased to the target doses over a 2-week period (Table 2). During Week 3, following overnight abstinence from smoking, participants will present for a laboratory Test Session in which they will have the option of cigarette self-administration. After this Test Session is completed, smokers will be maintained on their randomized medication condition for an additional 4-week period. Smokers will establish a quit date at the beginning of this Treatment Phase, and will receive brief weekly behavioral treatment for the 4 weeks of this phase. Additionally, at the beginning of Week 3, participants will be given a PDA that will administer EMA assessments. The study medication will be tapered after the end of Week 4 of the Treatment Phase. Participants will be contacted by phone at one week, and one month, after treatment termination to inquire about any adverse events and about their recent smoking status.
Interventions
DRUGplacebo
placebo compared to 8mg of Galantamine
DRUGGalantamine 8mg
8mg of galantamine compared to placebo
DRUGGalantamine 16mg
16mg of galantamine compared to placebo
Sponsors
National Institute on Drug Abuse (NIDA)
Yale University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
No
Inclusion criteria
* Female and male smokers, aged 18 to 55 years; * history of smoking daily for the past 12 months, at least 10 cigarettes daily; * in good health as verified by medical history, screening examination, and screening laboratory tests; * for women, not pregnant as determined by pregnancy screening, nor breast feeding, and using acceptable birth control methods.
Exclusion criteria
* History of GAL allergy; * requirement of any form of regular psychotropic medication (antidepressants, antipsychotics, or anxiolytics) and recent psychiatric history (in the past 6 months); * serious medical illness including asthma, diabetes, bradycardia, or other arrhythmias and major cardiovascular, renal, endocrine, or hepatic disorders; * abuse of alcohol or any other illicit or prescription drugs; * use of any other tobacco products, including smokeless tobacco and nicotine products; and * inability to fulfill all scheduled visits and examination procedures throughout the study period.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Smoking Choice Procedure | Data was acquired during a single test session during week 3 of drug intervention. | After overnight abstinence, participants will receive 10 tokens at the beginning of the smoking choice session. These tokens can be exchanged for money (0.75$ / token) or 2 cigarette puffs. The session starts with sample smoking of 2 puffs that allows subjective responses to me measured after abstinence. 15 min later, participants make their first choice, followed by 9 additional choices, every 15 minutes. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Placebo Placebo (sugar Pill) will be given daily for 7 weeks.
placebo: placebo compared to 8mg of galatamine | 17 |
| Galantamine 8mg Galantamine extended release (8mg) will be given daily for 7 weeks.
Galantamine 8mg: 8mg of galatamine compared to placebo | 21 |
| Galantamine 16mg Galantamine extended release (16mg) will be given daily for 5 weeks starting at week 3 after a two week titration with 8mg galantamine.
Galantamine 16mg: 16mg of galatamine compared to placebo | 22 |
| Total | 60 |
Baseline characteristics
| Characteristic | Placebo | Galantamine 8mg | Galantamine 16mg | Total |
|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 17 Participants | 21 Participants | 22 Participants | 60 Participants |
| Region of Enrollment United States | 17 participants | 21 participants | 22 participants | 60 participants |
| Sex: Female, Male Female | 6 Participants | 8 Participants | 10 Participants | 24 Participants |
| Sex: Female, Male Male | 11 Participants | 13 Participants | 12 Participants | 36 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 17 | 0 / 21 | 0 / 22 |
| other Total, other adverse events | 8 / 17 | 13 / 21 | 11 / 22 |
| serious Total, serious adverse events | 0 / 17 | 0 / 21 | 0 / 22 |
Outcome results
Primary
Smoking Choice Procedure
After overnight abstinence, participants will receive 10 tokens at the beginning of the smoking choice session. These tokens can be exchanged for money (0.75$ / token) or 2 cigarette puffs. The session starts with sample smoking of 2 puffs that allows subjective responses to me measured after abstinence. 15 min later, participants make their first choice, followed by 9 additional choices, every 15 minutes.
Time frame: Data was acquired during a single test session during week 3 of drug intervention.
Population: The number of participants analyzed per arm for this outcome is different than participant flow data because not every participant completed the smoking choice session.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Smoking Choice Procedure | 3.00 # of choices to smoke (out of 10) | Standard Deviation 3.08 |
| Galantamine 8mg | Smoking Choice Procedure | 1.00 # of choices to smoke (out of 10) | Standard Deviation 1 |
| Galantamine 16mg | Smoking Choice Procedure | 0.85 # of choices to smoke (out of 10) | Standard Deviation 1.35 |