Modafinil for the treatment of cocaine dependence.
OBJECTIVE
Modafinil was tested for efficacy in facilitating abstinence in cocaine-dependent patients, compared to placebo.


METHODS
This was a double-blind placebo-controlled study, with 12 weeks of treatment and a 4-week follow-up. Six outpatient substance abuse treatment clinics participated in the study. There were 210 treatment-seekers randomized, having a diagnosis of cocaine dependence; 72 participants were randomized to placebo, 69 to modafinil 200mg, and 69 to modafinil 400mg, taken once daily on awakening. Participants came to the clinic three times per week for assessments and urine drug screens, and had one hour of individual psychotherapy weekly. The primary outcome measure was the weekly percentage of cocaine non-use days.


RESULTS
The GEE regression analysis showed that for the total sample, there was no significant difference between either modafinil group and placebo in the change in average weekly percent of cocaine non-use days over the 12-week treatment period (p>0.79). However, two secondary outcomes showed significant effects by modafinil 200mg: the maximum number of consecutive non-use days for cocaine (p=0.02), and a reduction in craving (p=0.04). Also, a post hoc analysis showed a significant effect of modafinil that increased the weekly percentage of non-use days in the subgroup of those cocaine patients who did not have a history of alcohol dependence (p<0.02).


CONCLUSIONS
These data suggest that modafinil, in combination with individual behavioral therapy, was effective for increasing cocaine non-use days in participants without co-morbid alcohol dependence, and in reducing cocaine craving.
Anderson
Ann L
AL
Division of Pharmacotherapies and Medical Consequences of Drug Abuse, National Institute on Drug Abuse, National Institutes of Health, Bethesda, MD 20892-9551, USA. aa135m@nih.gov
Reid
Malcolm S
MS
Li
Shou-Hua
SH
Holmes
Tyson
T
Shemanski
Lynn
L
Slee
April
A
Smith
Edwina V
EV
Kahn
Roberta
R
Chiang
Nora
N
Vocci
Frank
F
Ciraulo
Domenic
D
Dackis
Charles
C
Roache
John D
JD
Salloum
Ihsan M
IM
Somoza
Eugene
E
Urschel
Harold C
HC
Elkashef
Ahmed M
AM
D000328:Adult; D000437:Alcoholism / Q000150:complications / Q000523:psychology; D001559:Benzhydryl Compounds / Q000009:adverse effects / Q000627:therapeutic use*; D000697:Central Nervous System Stimulants / Q000009:adverse effects / Q000627:therapeutic use*; D019970:Cocaine-Related Disorders / Q000150:complications / Q000188:drug therapy* / Q000523:psychology; D003131:Combined Modality Therapy; D004311:Double-Blind Method; D005006:Ethnicity; D005260:Female; D006801:Humans; D008297:Male; D000077408:Modafinil; D010349:Patient Compliance; D011569:Psychiatric Status Rating Scales; D011613:Psychotherapy; D012307:Risk Factors; D012959:Socioeconomic Factors; D016896:Treatment Outcome; D016482:Urinalysis
D001559:Benzhydryl Compounds; D000697:Central Nervous System Stimulants; D000077408:Modafinil