Efficacy and Safety of 24 Weeks Sustained-release Dexamphetamine in Patients With Moderate to Severe Cocaine Use Disorder With Comorbid Opioid Use Disorder - A Multicenter Randomized, Double-blind, Placebo-controlled Study
In The Netherlands, each year, about 15 thousand people come into treatment because of problems with cocaine use. There is no approved medication for treatment of cocaine addiction and the psychosocial treatment patients receive is not successful for everyone; many return to treatment several times. There is evidence that agonist (replacement) medications are effective in treating addiction: methadone for heroin addiction; nicotine replacement for smokers. Dexamphetamine is a stimulant medication registered for treatment of ADHD. It may also be effective as agonist treatment for people with cocaine addiction. It will be investigated whether sustained-release dexamphetamine in people with cocaine addiction, participating in routine methadone maintenance treatment for their comorbid opioid use disorder, (1) reduces cocaine use and (2) improves their health and quality of life.
• male and female patients between 18 years and over;
• actively participating in opioid agonist treatment with oral methadone;
• with moderate or severe cocaine use disorder according to DSM-5;
• with regular use of cocaine in the previous month (i.e., ≥8 days/month);
• with snorting, inhaling or injecting cocaine use as primary route of administration;
• express the intention to reduce or stop their cocaine use;
• be able and willing to attend the treatment center for 2 days per week;
• be able and willing to co-operate with the required study assessments and study procedures; and
• have provided written informed consent.