Table 1.
Randomized Placebo-Controlled Trials of Nicotinic Agonists that use a Clinician Rating of ADHD Symptoms as a Primary Outcome.
| RPCT [reference #] | Sample Sizea | Female | Age Mean (SD) | Research Design | Smoking Status | Duration of Treatment | Nicotinic Treatment | 1° Clinical Endpoint | 1° Clinical Measure Met (Y/N), Effect Size |
|---|---|---|---|---|---|---|---|---|---|
| Trials in Adults | |||||||||
| Levin et al., 2001 [51] | 34 | 37.5% | 19 – 56b | Between | Non-smokers | 4 weeks | Nicotine | CGI | No, N/A |
| Wilens et al., 2006 [48] | 11 | 45.5% | 32.0 (10.15) | Within | Non-smokers | 2 weeks | ABT-089 | CAARS-INV | Yes, ES=.92 |
| Apostol et al., 2012 [59] | 171 | 32% | 38.6 (11.34) | Within | Both | 4 weeks | ABT-089 | CAARS-INV | Yes, ES=.30 |
| Bain et al., 2012 [60] | 137 | 38% | 35.9 (N/A) | Between | Both | 8 weeks | ABT-089 | CAARS-INV | No, N/A |
| Wilens et al., 1999 [47] | 32 | 12% | 40.3 (9.4) | Within | Both | 3 weeks | ABT-418 | CGI or ARS | Yes, N/A |
| Bain et al., 2013 [62] | 196 | 47% | 36.2 (11.85) | Within | Both | 4 weeks | ABT-894 | CAARS-INV | Yes, ES=.45 |
| Potter et al., 2014 [64] | 24 | 25% | 44.3 (N/A) | Within | Non-smokers | 2 weeks | AZD3480 | CAARS-INV | Yes, ES (d)=.74 |
| Jucaite et al., 2014 [63] | 79 | 13% | 33.7 (N/A) | Within | Both | 2 weeks | AZD1446 | CAARS-INV | No, N/A |
| Trials in Children | |||||||||
| Shytle et al., 2002 [46] | 10 | 40% | 10 (0.8) | Between | Non-smokers | 7 days | Nicotine | CPRS and CGI | Yes, N/A |
| Wilens et al., 2011 [61]1 | 271 | 34% | 8.6 (N/A) | Between | Non-smokers | 8 weeks | ABT-089 | ADHD-RS-IV (HV) | No, N/A |
| Wilens et al., 2011 [61]2 | 115 | 34% | 8.5 (N/A) | Between | Non-smokers | 6 weeks | ABT-089 | ADHD-RS-IV (HV) | No, N/A |
Sample Size refers to number analyzed in the primary clinical measure (% Female and Age are from reported demographics)
mean (SD) not available, reported age range
Wilens et al., 2011 includes studies 1 and 2, here we report them individually
Wilens et al., 2011 includes studies 1 and 2, here we report them individually
Abbreviations: RPCT = Randomized Placebo Controlled Trial; Between = between subjects; Within = within subjects; N/A = not available; CPRS = Conner's Parent Rating Scale; CGI = Clinical Global Impression; AISRS = ADHD Investigator Symptom Report Scale; CAARS-INV = Conner's Adult ADHD Rating Scale, Investigator; ADHD-RS-IV (HV) TS = ADHD Rating Scale-IV Home Version; ARS = ADHD Rating Scale