A double-blind, placebo-controlled trial of reserpine for the treatment of cocaine dependence.
BACKGROUND
Cocaine's increase of dopamine is strongly associated with its reinforcing properties and, thus, agents that reduce dopamine have received much attention as candidate cocaine-dependence treatments. The potential efficacy of reserpine, a dopamine depletor, for treating cocaine dependence is suggested by both pre-clinical research and a small clinical trial.


METHODS
One hundred and nineteen participants who met DSM-IV criteria for cocaine dependence were enrolled into this 12-week, double-blind, placebo-controlled outpatient trial. Participants received either reserpine (0.5 mg/day) or matching placebo. All participants received 1h of manualized individual cognitive behavioral therapy on a weekly basis. Outcome measures included cocaine use as determined by self-report confirmed with urine benzoylecgonine results, cocaine craving, addiction severity index scores, and clinical global impression scores. Safety measures included adverse events, EKGs, vital signs, laboratory tests, and the Hamilton Depression Inventory.


RESULTS
Seventy-nine participants (i.e., 66%) completed the 12-week trial. The safety results suggest that reserpine was safe and well tolerated by the participants. The efficacy measures indicated no significant differences between reserpine and placebo.


CONCLUSIONS
These results do not support the efficacy of reserpine as a cocaine-dependence treatment.
Winhusen
Theresa
T
Department of Psychiatry, University of Cincinnati College of Medicine, 231 Albert Sabin Way, Cincinnati, OH 45267, USA. winhusen@mdru.uc.edu
Somoza
Eugene
E
Sarid-Segal
Ofra
O
Goldsmith
R Jeffrey
RJ
Harrer
Judy M
JM
Coleman
Florence S
FS
Kahn
Roberta
R
Osman
Sabuhi
S
Mezinskis
Juris
J
Li
Shou-Hua
SH
Lewis
Daniel
D
Afshar
Maryam
M
Ciraulo
Domenic A
DA
Horn
Paul
P
Montgomery
Margaret A
MA
Elkashef
Ahmed
A
D000281:Administration, Intranasal; D000328:Adult; D014150:Antipsychotic Agents / Q000627:therapeutic use; D001521:Behavior Therapy; D003042:Cocaine / Q000008:administration & dosage; D019970:Cocaine-Related Disorders / Q000188:drug therapy* / Q000523:psychology*; D003071:Cognition; D039721:Diagnostic and Statistical Manual of Mental Disorders; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D010919:Placebos; D012110:Reserpine / Q000627:therapeutic use*; D012907:Smoking
D014150:Antipsychotic Agents; D010919:Placebos; D012110:Reserpine; D003042:Cocaine