Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| R41DA033710 | U.S. NIH Grant/Contract | View source |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| National Institute on Drug Abuse (NIDA) | NIH |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The objective of this study is to compare the pharmacokinetics of an investigational 2 mg sublingual nicotine tablet (Pharmaceutical Productions Inc.) to a 2 mg Commit® nicotine lozenge (GlaxoSmith Kline) in a randomized crossover design in 6 male and female otherwise healthy smokers.
A single oral dose of each medication will be administered to each participant with a 48 hour washout period between administrations. Serial blood samples will be obtained at the following times after the administration of the nicotine dosage forms: 0, 4, 8, 10, 12, 16, 30, 45, 60, 90, 120, and 180 minutes. Vital signs will be obtained prior to dosing and at 30, 60, 180, and 240 minutes after dosage administration. A craving questionnaire will be administered prior to dosing and at 5, 11, 17, 25, 35, 50, and 65 minutes. Craving questionnaires will then be administered at 30 minute intervals thereafter up to 180 minutes after medication administration. A Product Preference Questionnaire will be completed at the end of the second study period. A 30 day follow-up visit will be scheduled with each participant at the conclusion of the study
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| sublingual nicotine tablet | Experimental | investigational 2 mg sublingual nicotine tablet |
|
| COMMIT nicotine lozenge | Active Comparator | COMMIT 2 mg nicotine lozenge |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nicotine (Pharmaceutical Productions Inc.) | Drug | An investigational 2 mg sublingual nicotine tablet (Pharmaceutical Productions Inc.) will be administered in a randomized crossover design in 6 male and female otherwise healthy smokers. |
| Measure | Description | Time Frame |
|---|---|---|
| The primary outcome measure is to substantiate that the pharmacokinetics of this novel nicotine replacement therapy (NRT) resembles that of smoking a cigarette, wherein the average Tmax is about 15 minutes or less. â–º | Serial blood samples will be obtained at the following times after the administration of the nicotine dosage forms: 0, 4, 8, 10, 12, 16, 30, 45, 60, 90, 120, and 180 minutes. |
| Measure | Description | Time Frame |
|---|---|---|
| The secondary outcome is to compare craving scores for this investigational nicotine replacement therapy (NRT) to the lozenge. | A craving questionnaire will be administered prior to dosing and at 5, 11, 17, 25, 35, 50, and 65 minutes. Craving questionnaires will then be administered at 30 minute intervals thereafter up to 180 minutes after medication administration. | A craving questionnaire will be administered prior to dosing and at 5, 11, 17, 25, 35, 50, and 65 minutes and will then be administered every 30 minute thereafter up to 180 minute. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Frank Vocci, Ph.D | Friends Research Institute, Inc. | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Friends Research Institute Clinic | Torrance | California | 90502 | United States |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Nicotine (Pharmaceutical Productions Inc.) | Drug | A Commit® 2 mg nicotine lozenge (GlaxoSmith Kline)will be administered in a randomized crossover design in 6 male and female otherwise healthy smokers. |
|
|
| A Product Preference Questionnaire | At the end of the second dosing day the participant will be asked to fill out the Patient Preference Questionnaire | At the end of the second dosing day. |
| ID | Term |
|---|---|
| D009538 | Nicotine |
| D061485 | Tobacco Use Cessation Devices |
| ID | Term |
|---|---|
| D012991 | Solanaceous Alkaloids |
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
| D011725 | Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D013812 | Therapeutics |
Not provided
Not provided