This story discusses modafinil (trade name Provigil) as a potential treatment for the withdrawal symptoms of cocaine addiction, such as fatigue, depression and lack of concentration. The drug may also blunt some of the desire for a cocaine “high”. While modafinil is listed as “legal”, the drug is not yet approved to treat cocaine addiction. Only small pilot studies have been conducted on the safety and effectiveness of the drug. Modafinil is currently only approved to treat narcolepsy and other sleep disorders. The story provides no information on the cost of taking this medication daily, and no estimate of how long someone experiencing cocaine withdrawal would need to take modafinil.
Treatment of cocaine addiction with modafinil is listed as new, and large scale, randomized clinical trails of the drug for this use have yet to be conducted. While early studies of the drug seem promising, the story gives no evidence regarding the effectiveness of this drug over other treatments and no information about the potential side effects of taking this drug. The discussion of modafinil allowing former cocaine addicts to “think strategically” is an overstatement, as there is no evidence in the pilot study of improved decision making with modafinil.
Insomnia is listed as a typical side effect of modafinil, but the story doesn’t describe how common this is in people who take the drug for withdrawal symptoms of cocaine dependence. In the pilot study mentioned, side effects were twice as common in the treatment group, and included nausea, anxiety, tachycardia, loss of appetite and urinary tract infection. Only 40 of 62 patients completed the 8-week study, though side effects are not listed as the reason for 22 patients not completing the study.
The story doesn’t discuss any other pharmacological, psychosocial or behavioral interventions for cocaine abuse, although cognitive behavioral therapy was part of the treatment for all patients in the pilot study mentioned. While treatment of the biochemical and physical symptoms of cocaine addiction is important, there are other variables involved in drug abuse, including negative psychological and environmental factors that are not blunted by the use of modafinil or any pharmacological treatment.
The pilot study principal investigator, who is interviewed in the story, is a hired speaker for Cephalon, maker of modafinil, though this is not mentioned in the article. The disclosure is readily available in the source journal article.
No mention of the cost of taking modafinil daily.
The story doesn’t give any quantitative evidence of the benefits of this drug over placebo to reduce withdrawal symptoms and cravings for cocaine, though this evidence is provided in the journal article for the small pilot study. Abstinence from cocaine was measured as clean urine tests and of the 24 test required, 43% of the modafinil group vs. 24% of the placebo group were without evidence of recent cocaine use. Futher evidence from larger randomized trials is needed. The discussion of modafinil allowing former cocaine user to “think strategically” might be an overstatement as there is no evidence in the pilot study of improved decision making with modafinil.
The story doesn’t mention the incidence of side effects in the pilot study or from other trials. Insomnia is mentioned in the story, but we’re not told how common this is in people who take the drug for withdrawal symptoms of cocaine dependence. Side effects were twice as common in the treatment group in the pilot study and included nausea, anxiety, tachycardia, loss of appetite and urinary tract infection.
The story doesn’t give any quantitative evidence or any description of the pilot study. This was a randomized, double-blind study of 62 cocaine addicted patients (mostly male) taking modafinil or placebo for 8 weeks. Cognitive behavioral therapy was also part of treatment for both groups. Only 40 patients completed the 8-week study, though reportedly none dropped out due to side effects of the medication.
No real evidence of disease mongering. The drug is promoted here to treat cocaine addiction and the incidence of this addiction is reported at 1.5 million in the U.S., however only about 250,000 were in substance abuse treatment (Substance Abuse and Mental Health Services Administration).
The story doesn’t mention any potential conflict of interest of the sources cited. Dr. Dackis is a hired speaker for Cephalon, maker of modafinil, though this is not mentioned in the news story. The disclosure is readily available in the source journal article.
The story doesn’t mention any other pharmacological, psychosocial or behavioral interventions, although cognitive behavioral therapy was part of the treatment for both the placebo and treatment groups in the pilot study conducted by Dr. Dackis and mentioned in the article.
While modafinil is “legal”, it is still only FDA approved to treat narcolepsy and some cases of obstructive sleep apnea. The drug is also approved to treat shift work sleep disorders (i.e. the inability to adjust sleep hours due to overnight shift work), as this CNS stimulant has fewer side effects than caffeine or amphetamines. It is not yet approved to treat cocaine addiction. While the story explains the drug’s current availability, it could have emphasized more clearly that the new use is still an unapproved use. Nonetheless, we give this a satisfactory score because of the cautions included in the story.
Treatment of cocaine addiction with modafinil is described as new and large scale clinical trails of the drug for this use have not been conducted. This drug is thought to reduce some of the withdrawal symptoms of cocaine addiction, such as fatigue, depression and blunt the desire for the euphoria or cocaine “high”.
No evidence this is taken from a press release. There are reputable sources from the NIH National Institute of Drug Abuse cited, in addition to the principal investigator of the pilot study.