An adaptive clinical trial design for cocaine use disorder: Extended-release amphetamine salts for early behavioral intervention non-responders

Blevins, Derek; Carpenter, Kenneth M.; Martínez, Diana; Mariani, John J.; Levin, Frances R.

doi:10.1016/j.cct.2020.106187

Cited by 4 publications

(4 citation statements)

References 39 publications

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“…MIXED AMPHETAMINE SALTS AS AN AUGMENTATION STRATEGY month of treatment (Blevins et al, 2020). SMART designs vary in complexity, breadth, and the data analytic strategies that can be employed (Nahum-Shani et al, 2020).…”

Section: Discussionmentioning

confidence: 99%

“…Previous studies have found significant interactions between CM protocols and pharmacotherapy (Schmitz et al, 2010; Tardelli et al, 2018), thus it is possible similar synergistic effects could have been detected if a different design was employed. Further, the sequential adaptive intervention employed was powered to address one specific question that focused on the effect of augmenting a behavioral intervention with a prescribed psychostimulant among individuals continuing to use cocaine after a month of treatment (Blevins et al, 2020). SMART designs vary in complexity, breadth, and the data analytic strategies that can be employed (Nahum-Shani et al, 2020).…”

Section: Discussionmentioning

confidence: 99%

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Mixed amphetamine salts–extended release (MAS-ER) as a behavioral treatment augmentation strategy for cocaine use disorder: A randomized clinical trial.

Carpenter,

Choi,

Basaraba

et al. 2024

Experimental and Clinical Psychopharmacology

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Psychosocial interventions remain the primary strategy for addressing cocaine use disorder (CUD), although many individuals do not benefit from these approaches. Amphetamine-based interventions have shown significant promise and may improve outcomes among individuals continuing to use cocaine in the context of behavioral interventions. One hundred forty-five adults (122 males) who used cocaine a minimum of 4 days in the prior month and met the criteria for a CUD enrolled in a two-stage intervention. All participants received a computer-delivered skills intervention and contingency management for reinforcing abstinence for a 1-month period. Participants demonstrating less than 3 weeks of abstinence in the first month were randomized to receive mixed amphetamine salts–extended release (MAS-ER) or placebo (80 mg/day) for 10 weeks under double-blind conditions. All participants continued with the behavioral intervention. The primary outcome was the proportion of individuals who achieved 3 consecutive weeks of abstinence as measured by urine toxicology confirmed self-report at the study end. The proportion of participants demonstrating 3 consecutive weeks of abstinence at study end did not differ between the medication groups: MAS-ER = 15.6% (7/45) and placebo = 12.2% (5/41). Participants who received MAS-ER reported greater reductions in the magnitude of wanting cocaine, although no group differences were noted in either the perceived improvement or the frequency of wanting cocaine. Retention rates were greater for both medication groups compared to behavioral responders. Overall, augmenting a behavioral intervention with MAS-ER did not significantly increase the abstinence rate among individuals continuing to use cocaine following a month of behavioral therapy alone.

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Section: Discussionmentioning

confidence: 99%

Section: Discussionmentioning

confidence: 99%

Mixed amphetamine salts–extended release (MAS-ER) as a behavioral treatment augmentation strategy for cocaine use disorder: A randomized clinical trial.

Carpenter,

Choi,

Basaraba

et al. 2024

Experimental and Clinical Psychopharmacology

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“…CUD remains a significant public health issue, and amphetamines are among the few medications showing promising therapeutic results [58]. Impairments in dopamine transmission predict non-responsiveness to behavioral therapy, underscoring the potential significance of drugs like MAS, which have substantial control over the dopaminergic system.…”

Section: Mixed Amphetamine Saltsmentioning

confidence: 99%

“…Impairments in dopamine transmission predict non-responsiveness to behavioral therapy, underscoring the potential significance of drugs like MAS, which have substantial control over the dopaminergic system. However, a number of medical, psychosocial, and practical factors, such as the possibility of abuse or diversion, health issues like cardiovascular disease, the worsening of psychiatric conditions like BD or anxiety disorders, and insurance coverage of off-label psychostimulants, make it difficult to treat cocaine or other stimulant use disorders with psychostimulants [58].…”

Section: Mixed Amphetamine Saltsmentioning

confidence: 99%

The Therapeutic Potential of Amphetamine-like Psychostimulants

Pires,

Rosendo,

Brinca

et al. 2023

Life

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This review delves into the therapeutic applications of amphetamine-type stimulants such as lisdexamphetamine dimesylate, mixed amphetamine salts, 3,4-methylenedioxymethamphetamine (MDMA), dextroamphetamine, and phentermine. These compounds have been investigated for their potential in treating a range of psychiatric disorders, including attention deficit hyperactivity disorder (ADHD), drug dependence, post-traumatic stress disorder (PTSD), and obesity. Lisdexamphetamine dimesylate has shown promise in effectively treating ADHD symptoms in both children and adults. Additionally, it has been explored as a potential treatment for drug dependency and withdrawal, demonstrating encouraging results. Mixed amphetamine salts have also exhibited efficacy in reducing ADHD symptoms in adults. Future research should explore their potential use in treating bipolar disorder and cocaine dependence, considering the associated risks and benefits. MDMA-assisted psychotherapy has emerged as an innovative approach to treating PTSD, leading to sustained reductions in symptoms and even promoting post-traumatic growth. Furthermore, it has shown promise in managing anxiety related to life-threatening illnesses. Dextroamphetamine and phentermine have demonstrated efficacy in treating cocaine and opioid dependence, ADHD, and obesity. However, careful consideration and monitoring by medical professionals are essential due to the potential risks and benefits associated with them. In conclusion, amphetamine-type stimulants present a promising avenue for therapeutic interventions in various psychiatric conditions. Nevertheless, further research is necessary to comprehensively understand their mechanisms of action, dosage requirements, and long-term effects in different patient populations.

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