The evaluation of the efficacy and safety of a transdermal delivery system of nicotine/mecamylamine in cigarette smokers
| ISRCTN | ISRCTN43027384 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN43027384 |
| Protocol serial number | N/A |
| Sponsor | Elan Corp (USA) |
| Funder | Elan Corp (USA) |
- Submission date
- 03/05/2006
- Registration date
- 05/06/2006
- Last edited
- 19/03/2010
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Other
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Elbert D Glover
Scientific
Scientific
University of Maryland
2387 HHP Building
College Park
Maryland
20742
United States of America
| Phone | +1 301 405 2467 |
|---|---|
| eglover1@umd.edu |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Multicenter (n=4), double-blind, randomized, parallel group, repeat dose study |
| Secondary study design | Randomised controlled trial |
| Scientific title | |
| Study objectives | To determine the efficacy and safety of nicotine transdermal therapy co-administered with the nicotine antagonist, mecamylamine; as compared to a nicotine transdermal patch alone (21 mg nicotine + 6 mg mecamylamine, 21 mg nicotine + 3 mg mecamylamine, and 21 mg nicotine + 0 mg mecamylamine). |
| Ethics approval(s) | Approved by the West Virginia University's Institutional Review Board in 1997, reference number: HS13781 |
| Health condition(s) or problem(s) studied | Cigarette smoking |
| Intervention | Treatment was administered for the first six weeks of the 8-week study. Patients were instructed to continue smoking for the first two weeks of treatment. Patients were randomised into one of the following groups: 1. 21 mg nicotine + 6 mg mecamylamine 2. 21 mg nicotine + 3 mg mecamylamine 3. 21 mg nicotine + 0 mg mecamylamine |
| Intervention type | Drug |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | Mecamylamine, nicotine |
| Primary outcome measure(s) | Analysis of the four-week continuous abstinence for the intent-to-treat population using the slip definition, which allows smoking in the first two weeks after the quit date. |
| Key secondary outcome measure(s) | Analysis of the four-week continuous abstinence for the intent-to-treat population using the strict definition (no smoking after the quit date). |
| Completion date | 31/12/1998 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | All |
| Target sample size at registration | 375 |
| Key inclusion criteria | 1. Males or females motivated to quit smoking between the ages of 18 and 70 years 2. Smoked at least 20 cigarettes a day for three years or more (smoking confirmed via expired CO level >10 ppm). All subjects had normal blood pressure and heart rate, weighed more than 100 pounds and typically no more than 130% of their ideal body weight, and expressed willingness to quit smoking on the specified target quit date (TQD). They were not currently using smokeless tobacco or other nicotine products. A detailed medical history, routine physical examination, laboratory tests and electrocardiogram (ECG) confirmed that subjects were in general good health. All women had a negative pregnancy test and agreed to use a medically accurate contraceptive method. |
| Key exclusion criteria | Participants were excluded if they had a history of significant hepatic, renal, endocrine, cardiac, psychiatric, gastrointestinal, pulmonary, or metabolic disorder including hyperthyroidism, pheochromocytoma, diabetes, severe coronary insufficiency, recent myocardial infarction (within 90 days), glaucoma, cerebrovascular disease, stroke, chronic renal failure, prostatic hypertrophy, prostatic disease, bladder neck obstruction, urine retention, urethral stricture, a history of atopic or eczematous dermatitis, psoriasis, or altered skin condition at patch application site. |
| Date of first enrolment | 01/01/1997 |
| Date of final enrolment | 31/12/1998 |
Locations
Countries of recruitment
- United States of America
Study participating centre
University of Maryland
Maryland
20742
United States of America
20742
United States of America
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/05/2007 | Yes | No |
