Tobacco Use Disorder
Conditions
Keywords
smoking, smoking cessation, cigarette
Brief summary
To evaluate the efficacy and safety of AZD8529 for smoking cessation in female smokers.
Detailed description
This is a 19-week, multi-center, randomized, Phase 2 clinical study comparing the efficacy of two different doses of AZD8529 (1.5 and 40 mg) in smoking cessation. Up to 2 weeks will be allowed for the Screening Period, followed by a 1-week, single-blind run-in period. At the end of Study Week 1 (on Study Day 8), medication compliance will be one of the factors used in a predictive enrichment strategy.
Interventions
DRUGAZD8529
comparison of different dosages of drug
Sponsors
National Institute on Drug Abuse (NIDA)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 75 Years
Healthy volunteers
Yes
Inclusion criteria
* Be a female smoker between the ages of 18 to 75 years. * Want to quit smoking. * Be currently (last 30 days) smoking 10 or more cigarettes per day and report less than 3 months of consecutive smoking abstinence during the past year. * Be able, in the opinion of the site investigator (SI), to understand and follow all protocol-specified instructions and understand and provide written informed consent. * Be willing to provide personal information for entry into a clinical trial registry. * Agree to use and continue using at least one acceptable contraceptive method (oral contraceptives, IUDs, contraceptive implants under the skin, contraceptive rings or patches or injections, diaphragms with spermicide, condoms with spermicide, or abstinence) or, if not of childbearing potential, must fulfill one of the following criteria at screening: post-menopausal defined as amenorrhea for at least 12 months and with follicle stimulating hormone (FSH) levels in the laboratory defined post-menopausal range and/or documentation of irreversible surgical sterilization by hysterectomy, bilateral oophorectomy or bilateral salpingectomy or tubal ligation verified by the Site Investigator. * Agree not to use any other smoking behavioral intervention (self-help or formal treatment), acupuncture, or other smoking cessation pharmacotherapy during the study. * Agree to refrain from using dietary/herbal supplements other than vitamins and minerals for 7 days prior to receiving study drug and throughout the 13-week treatment period. * Agree to attend all required clinic appointments (including 3 eye exams) during the course of the 19-week study.
Exclusion criteria
* Please contact the site for more information
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Abstinence | Weeks 10 - 13 | The number of subjects in each treatment group who are smoking abstinence during the last 4 weeks of the treatment phase (weeks 10 through 13) |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| AZD8529 Low Dose Participants received AZD8529 1.5 mg capsule orally once daily for 13 weeks | 104 |
| AZD8529 High Dose Participants received AZD8529 40 mg capsule orally once daily for 13 weeks | 110 |
| Total | 214 |
Baseline characteristics
| Characteristic | AZD8529 High Dose | Total | AZD8529 Low Dose |
|---|---|---|---|
| Age, Continuous | 47.3 years STANDARD_DEVIATION 9.63 | 47.8 years STANDARD_DEVIATION 9.47 | 48.3 years STANDARD_DEVIATION 9.34 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 12 Participants | 24 Participants | 12 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 97 Participants | 188 Participants | 91 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 1 Participants | 2 Participants | 1 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Asian | 1 Participants | 3 Participants | 2 Participants |
| Race (NIH/OMB) Black or African American | 29 Participants | 52 Participants | 23 Participants |
| Race (NIH/OMB) More than one race | 3 Participants | 6 Participants | 3 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) White | 76 Participants | 151 Participants | 75 Participants |
| Sex: Female, Male Female | 110 Participants | 214 Participants | 104 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 104 | 0 / 110 |
| other Total, other adverse events | 74 / 104 | 85 / 110 |
| serious Total, serious adverse events | 0 / 104 | 3 / 110 |
Outcome results
Primary
Abstinence
The number of subjects in each treatment group who are smoking abstinence during the last 4 weeks of the treatment phase (weeks 10 through 13)
Time frame: Weeks 10 - 13
Population: Subjects who received at least one dose of AZD8529 were included in this population.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| AZD8529 Low Dose | Abstinence | 10 Participants |
| AZD8529 High Dose | Abstinence | 11 Participants |