Tobacco Use Disorder
Conditions
Keywords
nicotine fading, Accu Drop, cigarette tapering, smoking cessation, motivational interviewing
Brief summary
The purpose of this study is to combine a smoke ending aid with behavioral treatment.
Detailed description
The prime objective of this Innovative Stage I A/B Behavioral Therapy Development Research project is to conduct a pilot study under randomized, double-blind, placebo controlled conditions, to provide preliminary estimation of the efficacy of a 6 week Accu Drop nicotine fading protocol used in conjunction with cigarette tapering to bring about termination of cigarette usage in moderate to heavy smokers (\*15 cpd) who are interested in smoking cessation. Both the experimental and control groups in this study will receive six weeks of the manually driven behavioral treatment by experienced and trained therapists. The experimental group (N=30) will also be prescribed active Accu Drops (AD&C) while the control condition (N=30) will be prescribed placebo Accu Drops (PD&C) very similar in appearance, viscosity, and taste to active Accu Drops. Completion of the study protocol and smoking cessation rates at 1 week, 1 month, and 6 months post-treatment will be the prime measures of efficacy. The findings of this study will provide sufficient preliminary indication for the efficacy of the experimental treatment and its extended investigation in a Phase II study or for its nonefficacy.
Interventions
BEHAVIORALBehavioral Therapy
Weekly behavioral therapy based on Project Match Motivational Therapy clinical manual plus systematic cigarette tapering.
Sponsors
National Institute on Drug Abuse (NIDA)
Peter Gariti
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
21 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
* 21 years of age or older, and no greater than 65 years of age * Medically stable * Smoke at least 15 filtered cigarettes daily * Motivated to quit smoking
Exclusion criteria
* Medically unstable * Currently psychiatrically unstable (schizophrenia, unstable psychosis, untreated major depression, active substance abuse within the past 6 months) * Pregnant
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Abstinence Rate | 1 year | The main outcome measures were rates of treatment completion and smoking abstinence. It was hypothesized that the nicotine blocking agent product would lead to higher treatment completion rates, higher abstinence rates, and fewer problems with withdrawal than the placebo group. |
Countries
United States
Participant flow
Recruitment details
Participants were recruited to a university based center for the study of addictions in 2002.
Pre-assignment details
The study used a real world design meaning that participants were randomized on the same day as their study eligibility evaluation.
Participants by arm
| Arm | Count |
|---|---|
| Accu Drop Plus Counseling Active product and systematic cigarette tapering plus counseling. | 30 |
| Placebo Accu Drop Plus Counseling Placebo product and systematic cigarette tapering plus counseling | 30 |
| Total | 60 |
Baseline characteristics
| Characteristic | Placebo Accu Drop Plus Counseling | Accu Drop Plus Counseling | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 30 Participants | 30 Participants | 60 Participants |
| Age, Continuous | 43.50 years STANDARD_DEVIATION 12 | 47.07 years STANDARD_DEVIATION 11.4 | 45.29 years STANDARD_DEVIATION 11.7 |
| Region of Enrollment United States | 30 participants | 30 participants | 60 participants |
| Sex: Female, Male Female | 20 Participants | 17 Participants | 37 Participants |
| Sex: Female, Male Male | 10 Participants | 13 Participants | 23 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 30 | 0 / 30 |
| serious Total, serious adverse events | 0 / 30 | 0 / 30 |
Outcome results
Primary
Abstinence Rate
The main outcome measures were rates of treatment completion and smoking abstinence. It was hypothesized that the nicotine blocking agent product would lead to higher treatment completion rates, higher abstinence rates, and fewer problems with withdrawal than the placebo group.
Time frame: 1 year
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Accu Drop Plus Counseling | Abstinence Rate | 3 participants |
| Placebo Accu Drop Plus Counseling | Abstinence Rate | 4 participants |