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To establish a dose-effect curve for nicotine's abuse potential as a function of nicotine dose and delivery rate. Pulsed IV nicotine administration will be used as it closely matches nicotine delivery by inhaled tobacco use.
Both sub-studies will enroll male and female tobacco cigarette smokers. This study will examine the feasibility of the proposed study parameters in a total of 10 completers. In a crossover design, participants will be tested under 5 conditions: 0.2 mg nicotine delivered over 2.5 minutes (5 pulsed-nicotine deliveries), 0.2mg nicotine delivered over 10 min (20 pulsed-nicotine deliveries), 1.0 mg nicotine delivered over 2.5 minutes (5 pulsed-nicotine deliveries) and 1.0 mg nicotine delivered over 10 min (20 pulsed-nicotine deliveries). The main outcome measures will be self-report drug effects and urges to smoke cigarettes.
The investigators hypothesize that the abuse potential and alleviation of smoking urges are produced by nicotine as a function of nicotine dose and delivery rate.
This study is complete with 13 enrolled and 10 completers
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| nicotine infusion 0.2mg | Experimental | nicotine infusion 0.2 mg nicotine delivered over 2.5 minutes (5 pulsed-nicotine deliveries) The day order will be randomized over 5 days. |
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| nicotine infusion 2.0mg | Experimental | 0.2mg nicotine delivered over 10 min (20 pulsed-nicotine deliveries), |
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| nicotine infusion 1.0mg | Experimental | 1.0 mg nicotine delivered over 2.5 minutes (5 pulsed-nicotine deliveries) |
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| nicotine infuison 1.0mg | Experimental | 1.0 mg nicotine delivered over 10 min (20 pulsed-nicotine deliveries). |
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| Saline | Placebo Comparator | saline delivered over 2minutes ,2.5minutes,10 minutes |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nicotine 0.2mcg/kg/s and 1.0mcg/kg/s | Drug | Nicotine infusion 0.2 mg nicotine delivered over 2.5 minutes (5 pulsed-nicotine deliveries), 0.2mg nicotine delivered over 10 min (20 pulsed-nicotine deliveries), 1.0 mg nicotine delivered over 2.5 minutes (5 pulsed-nicotine deliveries) and 1.0 mg nicotine delivered over 10 min (20 pulsed-nicotine deliveries). |
| Measure | Description | Time Frame |
|---|---|---|
| Heart rate will be used to see the dose effect | the dose-effect curves of nicotine dose and delivery rate in heart rate | During nicotine infusion max of ten minutes |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mehmet Sofuoglu, M.D.,Ph.D. | Yale University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Veterans Affairs Hospital | West Haven | Connecticut | 06516 | United States |
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| ID | Term |
|---|---|
| D016540 | Smoking Cessation |
| ID | Term |
|---|---|
| D015438 | Health Behavior |
| D001519 | Behavior |
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| ID | Term |
|---|---|
| D009538 | Nicotine |
| ID | Term |
|---|---|
| D012991 | Solanaceous Alkaloids |
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
| D011725 | Pyridines |
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placebo-controlled, mixed-design with nicotine dose as a between-subject and nicotine delivery rate as a within-subject factor.
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Participant will not know nicotine dose or rate of infusion.
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| D006573 |
| Heterocyclic Compounds, 1-Ring |