A screening trial of amantadine as a medication for cocaine dependence

Shoptaw, Steven; Kintaudi, Prudencia C.; Charuvastra, Charles; Ling, Walter

doi:10.1016/s0376-8716(01)00205-8

Cited by 50 publications

(24 citation statements)

References 19 publications

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“…With respect to the repeated binary outcomes of abstinence from cocaine, alcohol, and both, missing weeks were imputed as positive/use, which is a standard practice in clinical trials for which cocaine abstinence is a primary outcome (Shoptaw, Kintaudi, Charuvastra, & Ling, 2002). The protocol called for three urines to be collected per patient each week, yielding a possible 39 urines per patient, 6 during the 2-week pre-randomization phase, and 33 during the 11-week treatment phase.…”

Section: Discussionmentioning

confidence: 99%

A double blind, placebo-controlled trial that combines disulfiram and naltrexone for treating co-occurring cocaine and alcohol dependence

Pettinati

Kampman

Lynch

et al. 2008

Addictive Behaviors

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BACKGROUND-This is a double blind, placebo-controlled trial that evaluated the efficacy of disulfiram, naltrexone and their combination in patients with co-occurring cocaine and alcohol dependence.METHODS-208 patients were randomized to disulfiram (250mg/day), naltrexone (100mg/day), the combination, or placebo for 11 weeks. Outcomes were in-trial abstinence from cocaine and/or alcohol.RESULTS-Few safety concerns were reported, although medication adherence was low in a number of patients for both medications, alone or in combination. In the primary analyses (GEE modeling), abstinence from cocaine as measured by cocaine-negative urines and days of self-reported abstinence from cocaine or alcohol did not differ between placebo and any of the medication groups. However, patients taking disulfiram (alone or in combination) were most likely to achieve combined abstinence from cocaine and alcohol. Secondary analyses revealed that patients taking the disulfiramnaltrexone combination were most likely to achieve 3 consecutive weeks of abstinence from cocaine and alcohol.CONCLUSION-There was an association between disulfiram treatment and abstinence from cocaine and alcohol. More patients taking the disulfiram-naltrexone combination achieved 3 consecutive weeks of abstinence in treatment than placebo-treated patients.

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Section: Discussionmentioning

confidence: 99%

A double blind, placebo-controlled trial that combines disulfiram and naltrexone for treating co-occurring cocaine and alcohol dependence

Pettinati

Kampman

Lynch

et al. 2008

Addictive Behaviors

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“…In these analyses, missing urine screens were imputed as positive, which is a standard practice in clinical trials for which cocaine abstinence is a primary outcome (Shoptaw et al, 2002), although it does create a bias against treatment dropouts. Other repeated outcomes (CGI-O, CGI-S, TLFB, CSSA, BSCS, CCQ) were also analyzed using GEE models for continuous or count responses.…”

Section: Discussionmentioning

confidence: 99%

A Double-Blind, Placebo-Controlled Trial of Modafinil for Cocaine Dependence

Dackis

Kampman

Lynch

et al. 2004

Neuropsychopharmacol

343

193

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Despite years of active research, there are still no approved medications for the treatment of cocaine dependence. Modafinil is a glutamate-enhancing agent that blunts cocaine euphoria under controlled conditions, and the current study assessed whether modafinil would improve clinical outcome in cocaine-dependent patients receiving standardized psychosocial treatment. This was a randomized, double-blind, placebo-controlled trial conducted at a university outpatient center (from 2002 to 2003) on a consecutive sample of 62 (predominantly African American) cocaine-dependent patients (aged 25-63) free of significant medical and psychiatric conditions. After screening, eligible patients were randomized to a single morning dose of modafinil (400 mg), or matching placebo tablets, for 8 weeks while receiving manual-guided, twice-weekly cognitive behavioral therapy. The primary efficacy measure was cocaine abstinence based on urine benzoylecgonine levels. Secondary measures were craving, cocaine withdrawal, retention, and adverse events. Modafinil-treated patients provided significantly more BE-negative urine samples (p ¼ 0.03) over the 8-week trial when compared to placebos, and were more likely to achieve a protracted period (X3 weeks) of cocaine abstinence (p ¼ 0.05). There were no serious adverse events, and none of the patients failed to complete the study as a result of adverse events. This study provides preliminary evidence, which should be confirmed by a larger study, that modafinil improves clinical outcome when combined with psychosocial treatment for cocaine dependence.

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“…Dopaminergic Agents. Therapeutics such as methylphenidate and other medications (e.g., bromocriptine, pergolide, and amantadine), which act as dopamine agonists, also show limited efficacy in the treatment of cocaine addiction (Khantzian et al, 1984;Grabowski et al, 1997;Handelsman et al, 1997;Malcolm et al, 2000;Shoptaw et al, 2002). The efficacy of methylphenidate, however, may be apparent only in cocaine addicts with comorbid attention deficit/hyperactivity disorder rather than cocaine addicts in general (Gawin et al, 1985;Levin et al, 1998;Schubiner et al, 2002).…”

Section: Cocaine Addictionmentioning

confidence: 99%