Research

Narcolepsy Medication Modafinil Used to Treat Cocaine Use Disorder

There are currently no FDA-approved medications for the treatment of cocaine use disorder. A potentially effective medication is modafinil, a medication already approved to treat narcolepsy.

 WHAT PROBLEM DOES THIS STUDY ADDRESS?

Modafinil has been shown to reduce cocaine use (see here) and cocaine induced euphoria (see here) in some trials, while a recent trial showed no effect for modafinil when combined with cognitive-behavioral therapy (see here).

To better understand the potential therapeutic effect of modafinil on cocaine use disorder, the current study evaluated its effects but excluded individuals who also had a current alcohol use disorder (to isolate the effects of modafinil on cocaine use specifically).

HOW WAS THIS STUDY CONDUCTED?

This randomized controlled trial conducted by Kampman and colleagues recruited 94 individuals with DSM-IV cocaine dependence who were seeking treatment for their cocaine use. People with any additional current substance use disorders besides nicotine and cannabis were not eligible to participate.

Participants were randomized to receive 300 mg modafinil (n=47) or an identical placebo (n=47) daily for eight weeks. The groups were similar on demographics and baseline drug use characteristics. All participants also received weekly individual cognitive-behavioral therapy (CBT) based on the Project MATCH manual. Contingency management (CM) was used to increase attendance at assessments for all participants.

For each completed treatment visit, participants were able to draw from a bowl with 500 slips. Half had no monetary value while 1 was worth $100, 219 were worth $1, and 30 were worth $25. Urine samples were collected twice weekly. A participant was considered to be abstinent in a week they self-reported abstinence and had negative results for both urine samples.

WHAT DID THIS STUDY FIND?

Given that 33% of urine tests were missed, the authors performed the analysis in multiple ways to determine the effect of missing data on the results. In one method, ignoring missing weeks, found a significant effect in favor of abstinence for modafinil such that the odds of abstinence were 2.54 times higher in the modafinil group compared to placebo. This result was similar and significant (odds ratio: 2.45) when assuming urine tests missed prior to dropout were positive (i.e., the participant was not abstinent). With all missing urine tests considered positive, the result was again similar (odds ratio: 2.23) but no longer significant.

There was also a significant difference between groups for continuous abstinence from cocaine during the final three weeks of the trial.


Participants in the modafinil group were:

 

  • more likely to report low levels of cocaine craving intensity and duration, but not frequency
  • more likely to consider themselves “very much improved” on the Clinical Global Impression Scale.
  • no significant differences in the number of visits attended

This trial provides some additional evidence that modafinil may be more effective at promoting abstinence in individuals with cocaine use disorder than placebo. Additionally, relative to participants receiving placebo, those treated with modafinil experienced cravings that were less intense and lasted for less time, while they also felt more improved by the end of treatment.

This study had better rates of retention and trial completion than previous trials which may be due to the use of contingency management. While more research is needed to further substantiate results, this is the third trial with findings supporting the effectiveness of modafinil for the treatment of cocaine use disorder.

WHY IS THIS STUDY IMPORTANT

Cocaine use disorder has proven difficult to treat with psychosocial treatment alone, and there are currently no medications available to enhance treatment despite best efforts to identify effective pharmacotherapies.

With over 1.5 million Americans regularly using cocaine, it is important that effective treatments are available for those who may need them. Randomized controlled trials such as this are important for determining what medications are (or are not) effective for the treatment of cocaine use disorder.

Since both groups received CBT and CM, there is evidence that Modafinil has a benefit over and above these psychosocial treatments alone. Modafinil was well tolerated with few side effects

Not all medications will work for all patients, and it is important to recognize that this treatment may not be effective in other cocaine using populations such as people with common co-occurring alcohol or other drug use disorders.

LIMITATIONS
  1. This trial included a relatively small, homogenous sample of African American individuals using crack-cocaine so results may not generalize to other settings and populations.
  2. While medication adherence was high (90% or higher in each group), this was measured by pill count and may not be accurate.

NEXT STEPS

More randomized controlled trials in larger samples are needed to further substantiate these results. Studies with longer follow-up are also needed as the 8 week follow-up period from the current study may not be adequate for determining lasting impact of this treatment. Research should also focus on identifying the ideal dose of modafinil for treating cocaine use disorder.

BOTTOM LINE

  • For individuals & families seeking recovery: While no medications are currently approved for the treatment of cocaine use disorder, modafinil may be a possible option in the future. In the meantime, frequent visits and continued engagement over time with psychosocial treatments are associated with better outcomes.For scientists: Modafinil may be a potential treatment option for cocaine use disorder but larger randomized controlled trials with long-term treatment and follow-up assessments are needed to substantiate results and determine optimal dosing and which cocaine patients in particular are likely to benefit.For policy makers: It is known that medications for the treatment of opioid and alcohol use disorders are cost-effective adjuncts to psychosocial treatments (see here). To help individuals with cocaine use disorder in a similar manner, it is important to support research of pharmacotherapies for cocaine use disorder.For treatment professionals and treatment systems: Try to retain your patients with cocaine use disorder in treatment since this population has high rates of treatment drop. CM may be a helpful method for doing so.

CITATIONS

Kampman, K. M., Lynch, K. G., Pettinati, H. M., Spratt, K., Wierzbicki, M. R., Dackis, C., & O’Brien, C. P. (2015). A double blind, placebo controlled trial of modafinil for the treatment of cocaine dependence without co-morbid alcohol dependence. Drug Alcohol Depend, 155, 105-110. doi:10.1016/j.drugalcdep.2015.08.005

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