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Randomized Controlled Trial
. 2009 Sep 1;104(1-2):133-9.
doi: 10.1016/j.drugalcdep.2009.04.015. Epub 2009 Jun 26.

Modafinil for the treatment of cocaine dependence

Ann L Anderson  1 , Malcolm S Reid, Shou-Hua Li, Tyson Holmes, Lynn Shemanski, April Slee, Edwina V Smith, Roberta Kahn, Nora Chiang, Frank Vocci, Domenic Ciraulo, Charles Dackis, John D Roache, Ihsan M Salloum, Eugene Somoza, Harold C Urschel 3rd, Ahmed M Elkashef
Affiliations
Randomized Controlled Trial

Modafinil for the treatment of cocaine dependence

Ann L Anderson et al. Drug Alcohol Depend. .

Abstract

Aim: 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.

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Conflict of interest statement

Conflict of interest

Charles Dackis has served as a consultant to Cephalon. Eugene Somoza has served as a consultant to Catalyst Pharmaceutical Partners. Domenic Ciraulo has a clinical trials contract with Catalyst Pharmaceuticals. All other authors declare that they have no conflicts of interest, i.e., no actual or potential conflict of interest including any financial, personal or other relationships with other people or organizations within three (3) years of beginning the work submitted that could inappropriately influence, or be perceived to influence, this work.

Figures

Fig. 1
Fig. 1
Flow chart of participants in the clinical trial of modafinil for cocaine dependence. One pt. in each treatment group dropped out before the first dose of medication, i.e., ‘failed enrollment.’.
Fig. 2
Fig. 2
Study retention for participants in the placebo, 200 and 400 mg/day modafinil treatment groups. Shown are the percentage remaining from randomization to the day of the last study visit.
Fig. 3
Fig. 3
Treatment group’s average weekly% of cocaine non-use days (self-report confirmed by urine benzoylecgonine) in: (A) the total sample; and (B) non-alcohol-dependent, and (C) alcohol-dependent (current or lifetime per DSM-IV), by dose of modafinil 400 mg/day, 200 mg/day, or placebo, over 12 weeks. [Plots show observed Group means and Least Square Means fitted lines.]
See this image and copyright information in PMC

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