Table 4.
Drug effects.
| PIO 0 mg | PIO 15 mg | PIO 45 mg | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| De-nicotinized week |
Nicotinized week | De-nicotinized week |
Nicotinized week | De-nicotinized week |
Nicotinized week | |||||||
| Dependent measure | Day 5 | |||||||||||
| Nicotine self-administration | ||||||||||||
| Drug breakpoint | 586 (391) | 652 (266) | 691 (629) | 908 (654) | 960 (373) | 1004 (466) | ||||||
| Subjective effects | ||||||||||||
| BSL* | PK | BSL | PK | BSL | PK | BSL | PK | BSL | PK | BSL | PK | |
| DEQ (−4–4) | ||||||||||||
| Good | 0.1 (0.3) | 2.5 (0.4) | 0.7 (0.3) | 2.3 (0.4) | 0.5 (0.9) | 2.3 (1.5) | 0.6 (1.3) | 2.3 (1.3) | 0.4 (0.3) | 2.3 (0.3) | 0.1 (0.1) | 2.8 (0.3) |
| Like | 0.7 (0.4) | 2.1 (0.5) | 0.4 (0.5) | 2.0 (0.6) | 0.7 (0.6) | 1.7 (1.2) | 0.2 (0.5) | 2.1 (0.9) | 0.3 (0.4) | 1.5 (0.6) | −0.3 (0.2) | 2.1 (0.5) |
| NEB (0–100) | ||||||||||||
| High** | 67.8 (7.7) | 61.5 (10.5) | 70.4 (11.7) | 74.5 (13.5) | 81.7 (7.0) | 81.9 (5.8) | ||||||
| Like | 62.3 (10.8) | 54.6 (8.1) | 61.3 (16.5) | 65.4 (12.4) | 64.1 (10.5) | 71.3 (8.9) | ||||||
| VAS (0–100) | ||||||||||||
| Good | 19.2 (9.8) | 46.8 (11.6) | 19.6 (10.2) | 44.7 (11.2) | 15.2 (12.3) | 36.8 (14.6) | 14.5 (10.6) | 46.7 (13.6) | 11.5 (6.9) | 58.8 (9.6) | 1.8 (1.0) | 61.2 (9.4) |
| High | 5.6 (4.2) | 15.1 (6.5) | 5.6 (3.7) | 27.6 (8.0) | 5.9 (6.0) | 26.9 (14.3) | 6.8 (5.4) | 37.4 (13.4) | 8.6 (5.8) | 26.1 (10.7) | 4.5 (3.8) | 34.8 (9.4) |
| Craving | ||||||||||||
| BSL | TH*** | BSL | TH | BSL | TH | BSL | TH | BSL | TH | BSL | TH | |
| QSU (1–7) | ||||||||||||
| Desire for nicotine | 4.1 (0.7) | 3.3 (0.6) | 4.5 (0.6) | 4.0 (0.7) | 4.1 (1.2) | 3.1 (0.9) | 4.4 (0.9) | 2.2 (1.8) | 4.3 (0.6) | 2.7 (0.5) | 4.3 (0.7) | 2.3 (0.5) |
| Urge | 4.2 (0.6) | 3.4 (0.6) | 4.4 (0.6) | 4.0 (0.6) | 3.8 (1.0) | 2.5 (1.0) | 4.5 (1.0) | 2.0 (0.8) | 4.0 (0.6) | 2.8 (0.6) | 4.5 (0.6) | 2.1 (0.4) |
| Want cigarette | 3.8 (0.6) | 3.2 (0.6) | 3.8 (0.6) | 4.2 (0.7) | 3.6 (0.9) | 2.7 (1.2) | 4.0 (0.9) | 2.0 (0.8) | 3.2 (0.6) | 2.4 (0.6) | 3.3 (0.6) | 1.9 (0.4) |
| Dependent measure | Cue session | |||||||||||
| Neutral | Active | Neutral | Active | Neutral | Active | Neutral | Active | Neutral | Active | Neutral | Active | |
| Physiologic | ||||||||||||
| GSR | 0.7 (0.05) | 0.2 (0.10) | 0.1 (0.03) | 0.1 (0.05) | 0.8 (0.8) | .07 (0.10) | 0.1 (0.05) | 0.1 (0.03) | 0.03 (0.00) | 0.05 (0.01) | 0.03 (0.00) | 0.1 (0.03) |
| HR | 74.5 (2.1) | 74.1 (2.9) | 78.0 (3.9) | 77.0 (3.1) | 74.5 (4.8) | 73.5 (5.5) | 70.2 (8.0) | 75.0 (5.0) | 75.6 (2.4) | 73.7 (2.5) | 68.6 (4.7) | 72.0 (2.7) |
| SKT | 31.6 (1.1) | 32.4 (1.0) | 30.8 (1.1) | 31.4 (1.1) | 30.5 (2.5) | 34.2 (2.0) | 28.5 (2.2) | 30.8 (1.9) | 29.4 (1.2) | 29.8 (1.0) | 28.5 (1.0) | 29.4 (1.0) |
| Craving | ||||||||||||
| QSU: Sum | 36.1 (5.4) | 38.2 (5.7) | 35.5 (4.8) | 32.8 (4.7) | 30.8 (8.8) | 36.3 (4.4) | 32.3 (4.4) | 38.4 (4.9) | 32.9 (4.8) | 36.3 (4.4) | 32.3 (4.4) | 38.4 (4.9) |
| Subjective | ||||||||||||
| Perceived physiologic (0–4) | ||||||||||||
| Faster HR | 1.3 (0.2) | 1.7 (0.3) | 1.7 (0.3) | 1.7 (0.2) | 1.3 (0.4) | 1.8 (0.8) | 2.0 (0.8) | 2.0 (0.6) | 1.4 (0.2) | 2.0 (0.2) | 1.6 (0.3) | 2.0 (0.2) |
| Heavy stomach | 1.1 (0.1) | 1.4 (0.1) | 1.2 (0.1) | 1.5 (0.2) | 1.0 (0.2) | 1.4 (0.6) | 1.0 (0.4) | 1.8 (0.6) | 1.1 (0.1) | 1.3 (0.2) | 1.2 (0.1) | 1.5 (0.2) |
| Salivating | 1.2 (0.1) | 1.5 (0.2) | 1.2 (0.1) | 1.2 (0.2) | 1.4 (0.4) | 1.2 (0.6) | 1.0 (0.4) | 1.2 (0.4) | 1.3 (0.1) | 1.5 (0.3) | 1.4 (0.1) | 1.4 (0.1) |
| Sweating hands | 1.0 (0.0) | 1.0 (0.0) | 1.0 (0.0) | 1.0 (0.0) | 1.0 (0.2) | 1.0 (0.0) | 1.2 (0.4) | 1.1 (0.3) | 1.0 (0.0) | 1.1 (0.1) | 1.0 (0.0) | 1.1 (0.1) |
| Trembling | 1.0 (0.0) | 1.0 (0.0) | 1.0 (0.0) | 1.1 (0.1) | 1.0 (0.2) | 1.2 (0.4) | 1.0 (0.2) | 1.4 (0.6) | 1.0 (0.0) | 1.3 (0.2) | 1.1 (0.1) | 1.3 (0.2) |
a
Mean baseline (BSL) or mean peak (PK: maximal drug effects throughout the session).
b
Not measured at baseline.
c
Mean trough (TH): minimum drug effects throughout the session.