Table 2.
Adverse events during the 2nd study week for each treatment group.
| Group | |||
|---|---|---|---|
| Adverse Event | PBO BID (N = 10) |
20 mg BID (N = 11) |
40 mg BID (N = 10) |
| Agitation | 1 (10%) | ||
| Anorexia | 1 (9.1%) | 2 (20%) | |
| Anxiety | 1 (10%) | 2 (20%) | |
| Backache | 1 (9.1%) | ||
| Chills | 1 (10%) | ||
| Constipation | 1 (10%) | 1 (9.1%) | 1 (10%) |
| Ear Infection | 1 (10%) | ||
| Fatigue | 1 (9.1%) | 1 (10%) | |
| GI Upset | 2 (20%) | 1 (9.1%) | 1 (10%) |
| Headache | 1 (10%) | ||
| Heartburn | 1 (10%) | ||
| Hot Flashes | 1 (10%) | ||
| Irritable | 1 (10%) | 1 (10%) | |
| Insomnia | 2 (20%) | 2 (18.2%) | 3 (30%) |
| Itchiness | 1 (10%) | 1 (9.1%) | |
| Leg Cramps | 1 (10%) | ||
| Muscle Aches | 1 (10%) | ||
| Nausea | 2 (20%) | 1 (10%) | |
| Runny Nose | 1 (10%) | ||
| Sore Throat | 1 (10%) | ||
| Sweating | 1 (10%) | 1 (10%) | |
| Tremors | 2 (20%) | ||
| Vomiting | 1 (10%) | ||
Adverse effects of ibudilast are reported for week 2, when administration of study medication was initiated. During this period, volunteers were stabilized on morphine and therefore not experiencing opioid withdrawal symptoms.