Sustained-release dexamfetamine in the treatment of chronic cocaine-dependent patients on heroin-assisted treatment: a randomised, double-blind, placebo-controlled trial

Nuijten, Mascha; Blanken, Peter; Wetering, Ben van de; Nuijen, Bastiaan; Brink, Wim van den; Hendriks, Vincent M.

doi:10.1016/s0140-6736(16)00205-1

Cited by 70 publications

(63 citation statements)

References 26 publications

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“…Amphetamine maintenance also decreased cocaine self-administration maintained under other, non-choice schedules of reinforcement in rhesus monkeys and rats (Chiodo et al, 2008; Czoty et al, 2010; Negus and Mello, 2003a, 2003b), as well as cocaine choice in human laboratory studies and metrics of cocaine use in clinical trials (Grabowski et al, 2001; Levin et al, 2015; Nuijten et al, 2016; Rush et al, 2010; Stoops and Rush, 2013). The present proof-of-concept study used intravenous administration to permit precise control of the lisdexamfetamine dose, although an oral formulation is approved for use in humans and would likely be used in clinical studies.…”

Section: Discussionmentioning

confidence: 95%

“…Lisdexamfetamine is an amphetamine prodrug approved for treatment of ADHD and compulsive eating disorder (Blick and Keating, 2007; Hutson et al, 2014), and it was selected for initial testing because preclinical and clinical research suggests that it might also be useful for treating cocaine use disorder (Banks et al, 2015; Mooney et al, 2015). Furthermore, maintenance on its metabolite, d-amphetamine, has been shown to decrease cocaine self-administration across a broad range of experimental conditions in rats, rhesus monkeys, human-laboratory studies, and placebo-controlled, double-blind clinical trials (Herin et al, 2010; Negus and Henningfield, 2015; Nuijten et al, 2016). Each lisdexamfetamine dose was tested using a subchronic, 7-day treatment regimen, because medications to treat drug use disorders are administered chronically in humans, and it has been argued that preclinical animal- and human-laboratory studies should also evaluate effects of repeated treatment delivery to more accurately predict clinical effectiveness (Czoty et al, 2016b; Banks et al, 2015a; Haney and Spealman, 2008; Mello and Negus, 1996).…”

Section: Introductionmentioning

confidence: 99%

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Development of a translational model to screen medications for cocaine use disorder I: Choice between cocaine and food in rhesus monkeys

Johnson

Banks

Blough

et al. 2016

Drug and Alcohol Dependence

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Background Homologous cocaine self-administration procedures in laboratory animals and humans may facilitate translational research for medications development to treat cocaine dependence. This study, therefore, sought to establish choice between cocaine and an alternative reinforcer in rhesus monkeys responding under a procedure back-translated from previous human studies and homologous to a human laboratory procedure described in a companion paper. Methods Four rhesus monkeys with chronic indwelling intravenous catheters had access to cocaine injections (0, 0.043, 0.14, or 0.43 mg/kg/injection) and food (0, 1, 3, or 10 1g banana-flavored food pellets). During daily 5h sessions, a single cocaine dose and a single food-reinforcer magnitude were available in 10 30-min trials. During the initial “sample” trial, the available cocaine and food reinforcer were delivered non-contingently. During each of the subsequent nine “choice” trials, responding could produce either the cocaine or food reinforcer under an independent concurrent progressive-ratio schedule. Results Preference was governed by the cocaine dose and food-reinforcer magnitude, and increasing cocaine doses produced dose-dependent increases in cocaine choice at all food-reinforcer magnitudes. Effects of the candidate medication lisdexamfetamine (0.32–3.2 mg/kg/day) were then examined on choice between 0.14 mg/kg/injection cocaine and 10 pellets. Under baseline conditions, this reinforcer pair maintained an average of approximately 6 cocaine and 3 food choices. Lisdexamfetamine dose-dependently decreased cocaine choice in all monkeys, but food choice was not significantly altered. Conclusions These results support utility of this procedure in rhesus monkeys as one component of a platform for translational research on medications development to treat cocaine use disorder.

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Section: Discussionmentioning

confidence: 95%

Section: Introductionmentioning

confidence: 99%

Development of a translational model to screen medications for cocaine use disorder I: Choice between cocaine and food in rhesus monkeys

Johnson

Banks

Blough

et al. 2016

Drug and Alcohol Dependence

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“…Studies conducted by Grabowski et al (2001, 2004b), Mooney et al (2009), as well as Nuijten et al (2016) found that amphetamines were more likely than placebo to promote abstinence among cocaine dependent individuals not specifically diagnosed with ADHD. However, abstinence did not occur immediately; instead, it required several weeks, as stimulant medication was titrated to a robust dose.…”

Section: Discussionmentioning

confidence: 97%

How treatment improvement in ADHD and cocaine dependence are related to one another: A secondary analysis

Levin

Choi

Pavlicová

et al. 2018

Drug and Alcohol Dependence

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Background: Attention-deficit hyperactivity disorder (ADHD) is overrepresented among individuals seeking treatment for substance use disorders. We previously reported that treatment with extended release mixed amphetamine salts (MAS-XR) increased abstinence, compared to placebo, among patients with co-occurring ADHD and cocaine dependence. This secondary analysis investigates the temporal relationship between ADHD improvement and cocaine abstinence in the first six weeks of the trial. Methods: The study was a three-arm, randomized, double-blinded, placebo-controlled, 14-week trial comparing MAS-XR (60 mg or 80 mg daily) versus placebo among 126 participants with ADHD and cocaine dependence. An autoregressive cross-lagged structural equation model was fit and evaluated weekly ADHD improvement (de-fined as ≥30% reduction in the Adult ADHD Investigator Symptom Rating Scale) and urine-confirmed abstinence over the first six weeks. Results: The proportion of patients with each of the possible overall patterns of response was: ADHD improves before cocaine abstinence: 24%; Cocaine abstinence occurs before ADHD improvement: 12%; ADHD improvement and abstinence occur during the same week: 6%; ADHD improves but abstinence never achieved: 34%; Abstinence achieved but ADHD never improves: 6%; Neither ADHD improvement nor abstinence: 18%. A significant cross-lagged association was found; subjects with ADHD improvement at week 2 had significantly higher odds of cocaine abstinence at week 3 (p = .014). Conclusion: When treating co-occurring ADHD and cocaine dependence with stimulant medication, abstinence is most likely preceded by improvement in ADHD, which tends to occur early with medication treatment. Other observed temporal patterns suggest the potential complexity of the relationship between ADHD and cocaine dependence.

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“…MPH has been suggested as a substitute drug for cocaine addicts, but the sufficiency has been unsatisfactory [81]. However, recent work shows efficacy in the application of sustained-release dexamfetamine on cocaine abuse in individuals with comorbid cocaine and heroin dependence [82]. Though the reasons for the low rate of ADHD treatment coverage in this population are largely subject to speculation, there may have been a general reluctance regarding stimulant prescription to a substance addicted population due to the risk of abuse or diversion which among a forensic population is deemed to be heightened [83].…”

Section: Discussionmentioning

confidence: 99%

Attention-Deficit Hyperactivity Disorder Symptom Status in a Mixed Gender Population of Opioid-Maintained Prison Inmates

et al. 2019

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Objective: Attention-deficit hyperactivity disorder (ADHD) often coincides with substance abuse and delinquency. A sample of opioid-maintained inmates was assessed for symptoms of ADHD, substance abuse history, types of offense, psychiatric comorbidities, and psychopharmacological treatment using a standardized battery of instruments. Method: Adult inmates (n = 133, mean age 35.7 years, 21.8% female) in opioid-maintenance therapy (OMT) were administered the Adult ADHD self-report scale, Wender Utah Rating Scale, Mini International Neuropsychiatric Interview, European Addiction Severity Index. Results: Fifty percent screened positive for childhood and 17% for adult ADHD, four (3.1%) received ADHD medication. Inmates with ADHD symptom status were significantly younger at first substance abuse, reported more drug overdoses, longer duration of cocaine and prescribed medication abuse and more in- and outpatient treatments (all p < 0.05). For all inmates in OMT a high rate of psychiatric comorbidities was observed (78.9%). Conclusion: There is a need for assessment of ADHD and other psychiatric comorbidities in OMT prisoners. Evidence-based treatment should be routinely provided.

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Sustained-release dexamfetamine in the treatment of chronic cocaine-dependent patients on heroin-assisted treatment: a randomised, double-blind, placebo-controlled trial

Cited by 70 publications

References 26 publications

Development of a translational model to screen medications for cocaine use disorder I: Choice between cocaine and food in rhesus monkeys

Development of a translational model to screen medications for cocaine use disorder I: Choice between cocaine and food in rhesus monkeys

How treatment improvement in ADHD and cocaine dependence are related to one another: A secondary analysis

Attention-Deficit Hyperactivity Disorder Symptom Status in a Mixed Gender Population of Opioid-Maintained Prison Inmates

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