An adaptive clinical trial design for cocaine use disorder: Extended-release amphetamine salts for early behavioral intervention non-responders
| Autor: | Diana Martinez, Kenneth M. Carpenter, Frances R. Levin, John J. Mariani, Derek Blevins |
|---|---|
| Rok vydání: | 2020 |
| Předmět: |
Adult
Adolescent media_common.quotation_subject Contingency management Placebo Article Young Adult 03 medical and health sciences 0302 clinical medicine Quality of life (healthcare) Cocaine Intervention (counseling) Humans Medicine Pharmacology (medical) 030212 general & internal medicine Amphetamine media_common Clinical Trials as Topic Adaptive clinical trial 030505 public health business.industry General Medicine Middle Aged Abstinence Treatment Outcome Quality of Life Salts 0305 other medical science business Psychosocial medicine.drug Clinical psychology |
| Zdroj: | Contemp Clin Trials |
| ISSN: | 1551-7144 |
| DOI: | 10.1016/j.cct.2020.106187 |
| Popis: | Background/aims Cocaine use disorder (CUD) persists as a major public health problem in the United States. Response to evidence-based behavioral treatment has been shown to be predicted by dopaminergic dysfunction. Amphetamine formulations modulate dopaminergic systems and are one of the few agents with positive clinical findings but are associated with unique risks. We aimed to find a model for determining the most appropriate patients for treatment with mixed amphetamine salts-extended-release (MAS-ER) for CUD using an adaptive trial design. Methods We are enrolling treatment-seeking adults ages 18–60 years. All eligible participants receive bi-weekly individual counseling augmented with a computer-based intervention based on the community reinforcement approach with contingency management (CRA + CM) for 4 weeks. Participants who fail to achieve abstinence are additionally randomly assigned to 10 weeks of either MAS-ER, titrated up to 80 mg daily, or placebo. All participants complete a follow-up assessment after 12 weeks. Results Frequency and amount of cocaine use, cravings, retention, and quality of life will be compared between groups. The primary outcome will be having at least 3 weeks of urine toxicology-confirmed self-reported abstinence. Analyses will also be conducted to identify variables that may help identify who is more or less likely respond to the behavioral intervention during the first 4-weeks of treatment. Conclusions This trial more closely mimics a personalized medicine approach that is often used in clinical practice. It will help us understand who may be appropriate for psychostimulant therapy as an enhancement to evidence-based behavioral interventions, while limiting exposure to those who would respond to a psychosocial intervention alone. ClinicalTrials.gov Identifier: NCT01986075 |
| Databáze: | OpenAIRE |
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