Cocaine dependence is a common and serious condition, associated with severe medical, psychological, and social problems. 1 Evidence on effective pharmacological interventions for cocaine addiction is sparse. Trials focusing on the use of antidepressants, carbamazepine, dopamine agonists, disulfiram, and other drugs used in the treatment of cocaine dependence have been carried out with mixed results. 2,3 It has been suggested that agents increasing brain dopamine activity, such as dopamine agonists, might have therapeutic benefit in cocaine dependence, and the use of dopamine agonists should decrease the effect of cocaine through a crosstolerance mechanism, similar to the methadone treatment strategy for heroin dependence.Pramipexole, cabergoline, and ropinirole are dopamine agonists active on D2, D3, and D4 receptors, all of which have proven safe and efficacious in the treatment of Parkinson's disease.To date, only case reports have been published supporting the efficacy and safety of pramipexole in the treatment of cocaine addiction, 4 while a recent controlled pilot trial of cabergoline reported encouraging evidence in the treatment of cocaine dependence. 5 To our knowledge, no clinical study has been conducted yet to test the efficacy and safety of ropinirole, a specific D2-like receptors ligand, in the treatment of cocaine addiction. We conducted a 12-week prospective pilot open-label clinical trial to provide preliminary evidence. The Bioethics Committee of Pisa approved the design of this study without requiring a control group considering that our trial is the pilot open-label study regarding ropinirole for cocaine dependence and that standard medications are not available for cocaine addiction to date. This study has been performed in accordance with the ethical standards laid down in the 1964 Declaration of Helsinki. Written informed consent was obtained from each participant.We enrolled thirty-nine subjects with cocaine dependence, with the following exclusions: r those with cocaine abuse, to observe the response in severe cocaine use; r those dependent on substances other than cocaine, for the possible interference; r those with current Axis I Disorders, to avoid the reduction in cocaine use being interpreted as a consequence of remission of other Axis I disordersespecially affective disorders, in which ropinirole could have a beneficial effect for an antidepressant action; and r those with a concomitant pharmacological treatment.No psycotherapeutic or social intervention was performed during the trial. Outcome measures included retention in treatment, side and adverse events, and positive results at toxicology screening urinalysis (tested twice a week), which provides an objective measure of cocaine use.Open-label ropinirole was begun at 0.75 mg/day (three times a day) for the first 7 days and then titrated to 1.5 mg/day (three times a day) on the next 11 weeks. Thirty subjects (77%) completed the study, and 9 (23%) dropped-out.The average rates of benzoylecgonine-positive urines decreased from 90.2...
