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

• Status: Not yet recruiting
• Trial end date: 2026-09-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Parnassia Addiction Research Centre
• Collaborators: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA); Columbia University; Het Zwarte Gat; Leiden University Medical Center; Radboud University Medical Center; The Netherlands Cancer Institute
• Treatments: Dextroamphetamine

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.