Efficacy and Safety of Sustained-release Dexamphetamine in Patients With Moderate to Severe Cocaine Use Disorder

Launched by PARNASSIA ADDICTION RESEARCH CENTRE · Sep 6, 2022

Keywords

ClinConnect Summary

This clinical trial is studying the use of a medication called sustained-release dexamphetamine to help people with moderate to severe cocaine use disorder. Many individuals struggle with cocaine addiction, and unfortunately, there are currently no approved medications specifically for this issue. Instead, they often rely on psychosocial treatments, which don't work for everyone. This trial aims to find out if dexamphetamine, which is already used to treat ADHD, can reduce cocaine use and improve the overall health and quality of life for patients who are also receiving methadone for opioid addiction.

To participate in this trial, individuals must be between 18 and 65 years old, currently using methadone for opioid addiction, and have a history of cocaine use in the past month. They should be motivated to reduce or stop their cocaine use and be willing to attend treatment sessions twice a week. Participants will undergo assessments for about 30 weeks, and they will need to provide their consent to join the study. It’s important to note that certain medical conditions may exclude someone from participating, such as severe heart problems or current severe mental health issues. If you or someone you know is interested and meets these criteria, this trial could provide a new treatment option for cocaine addiction.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • male and female patients between 18 and 65 years of age;
• • active participation in opioid agonist treatment with oral methadone;
• • moderate or severe cocaine use disorder according to DSM-5;
• • regular use of cocaine in the previous month (i.e., ≥8 days/month);
• • snorting, inhaling or injecting cocaine use as primary route of administration;
• • the intention to reduce or stop cocaine use;
• • able and willing to attend the treatment centre for 2 days per week;
• • able and willing to co-operate with the required study assessments and study procedures; and
• • provide written informed consent.
• Exclusion Criteria:
• • severe medical (e.g., severe renal or kidney insufficiency/failure) or severe psychiatric problems (e.g. acute psychosis, current major depression, current bipolar disorder, acute suicidality);
• • cardiovascular problems: clinically relevant ECG abnormalities, moderate to severe hypertension (SBP\>140; DBP\>90; HR\>100), angina pectoris, history with myocardial infarction, CVA, heart failure;
• • glaucoma;
• • Gilles-de-la-Tourettesyndrome;
• • pheochromocytoma;
• • hyperthyroid status;
• • current dyspnea;
• • pregnancy or continued lactation;
• • (indication for) treatment with other medications that might potentially be effective for stimulant use disorder (e.g., methylphenidate, disulfiram, bupropion, or modafinil);
• • anticipated need for inpatient treatment (clinical judgement);
• • (expected) inability to complete the 30 weeks study (e.g., due to expected incarceration or hospitalization);
• • insufficient command of the Dutch language; and
• • current participation in another addiction treatment study.