A medication screening trial evaluation of reserpine, gabapentin and lamotrigine pharmacotherapy of cocaine dependence.
OBJECTIVE
To conduct a preliminary evaluation of the safety and efficacy of reserpine, gabapentin or lamotrigine versus an unmatched placebo control as a treatment for cocaine dependence.


METHODS
A 10-week out-patient study using the Cocaine Rapid Efficacy and Safety Trial (CREST) study design.


METHODS
The study was conducted at the Cincinnati Medication Development Research Unit (MDRU).


METHODS
Participants met Diagnostic and Statistical Manual version IV (DSM-IV) criteria for cocaine dependence. Sixty participants were enrolled, with 50 participants completing the final study measures.


METHODS
The targeted daily doses of medication were reserpine 0.5 mg, gabapentin 1800 mg and lamotrigine 150 mg. All participants received 1 hour of manualized individual cognitive behavioral therapy on a weekly basis.


METHODS
Primary outcome measures of efficacy included urine benzoylecgonine (BE) level, Cocaine Clinical Global Impression scale--observer and self-report of cocaine use. Safety measures included adverse events, electrocardiograms (ECGs), vital signs and laboratory tests.


RESULTS
Subjective measures of cocaine dependence indicated significant improvement for all study groups. Urine BE results indicated a significant improvement for the reserpine group (P < 0.05) and non-significant changes for the other study groups. No pattern of physical or laboratory abnormalities attributable to treatment with any of the medications was identified. There were three serious adverse events reported, none of which were related to study procedures. The medications appeared to be tolerated well.


CONCLUSIONS
The present findings suggest that reserpine may be worthy of further study as a cocaine dependence treatment.
Berger
S Paul
SP
Cincinnati VA/UC NIDA MDRU, VA Medical Center, Cincinnati, OH, USA. bergerp@ohsu.edu
Winhusen
Theresa M
TM
Somoza
Eugene C
EC
Harrer
Judy M
JM
Mezinskis
Juris P
JP
Leiderman
Deborah B
DB
Montgomery
Margaret A
MA
Goldsmith
R Jeffrey
RJ
Bloch
Daniel A
DA
Singal
Bonita M
BM
Elkashef
Ahmed
A
D000328:Adult; D000588:Amines / Q000627:therapeutic use*; D000927:Anticonvulsants / Q000627:therapeutic use*; D014150:Antipsychotic Agents / Q000627:therapeutic use*; D019970:Cocaine-Related Disorders / Q000534:rehabilitation*; D003509:Cyclohexanecarboxylic Acids / Q000627:therapeutic use*; D005260:Female; D000077206:Gabapentin; D006801:Humans; D000077213:Lamotrigine; D008297:Male; D008875:Middle Aged; D010349:Patient Compliance; D012110:Reserpine / Q000627:therapeutic use*; D014227:Triazines / Q000627:therapeutic use*; D005680:gamma-Aminobutyric Acid / Q000627:therapeutic use*
D000588:Amines; D000927:Anticonvulsants; D014150:Antipsychotic Agents; D003509:Cyclohexanecarboxylic Acids; D014227:Triazines; D005680:gamma-Aminobutyric Acid; D000077206:Gabapentin; D012110:Reserpine; D000077213:Lamotrigine