REDUCE: Research on sustained-release dexamphetamine treatment for cocaine use disorder

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Parnassia Groep B.V.

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Psychiatry and Psychology [F] - Mental Disorders [F03]

Trial duration

12 Mar 2026 → ongoing

Decision date (initial)

2024-11-04

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

No

Funding sources

ZonMw · Di-AcetylM B.V.

External identifiers

EU CT number

2023-505556-21-00

ClinicalTrials.gov

NCT05529927

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Efficacy, Safety

To evaluate the efficacy of 24 weeks SR-dexamphetamine (individually titrated to a maximum dosage of 90 mg/day, as tolerated), compared with 24 weeks placebo, in patients with moderate/severe cocaine use disorder, in routine opioid agonist treatment with oral methadone for their comorbid opioid dependence in terms of days of cocaine abstinence and overall health status.

Secondary objectives 2

1. To assess the acceptance, tolerability, and safety of 24 weeks sustained-release dexamphetamine.
2. To evaluate the effect of discontinuation of sustained-release dexamphetamine after 24 weeks treatment.

Conditions and MedDRA coding

cocaine use disorder

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 8

1. actively participating in opioid agonist treatment with oral methadone
2. with moderate or severe cocaine use disorder according to DSM-5
3. with regular use of cocaine in the previous month
4. with snorting, inhaling or injecting cocaine use as primary route of administration
5. express the intention to reduce or stop their cocaine use
6. be able and willing to attend the treatment center for 2 days per week
7. be able and willing to co-operate with the required study assessments and study procedures
8. have provided written informed consent

Exclusion criteria 13

1. severe medical (e.g., severe renal or hepatic insufficiency/failure) or severe psychiatric problems (e.g. severe previous or acute psychotic episode, acute suicidality, current bipolar disorder)
2. cardiovascular problems: clinically relevant ECG abnormalities suggestive of channelopathy or structural or ischemic heart disease; moderate to severe hypertension (i.e., SBP>140; DBP>90); HR>100, known coronary artery disease (i.e., angina pectoris, acute myocardial infarction), known cardiomyopathy, CVA
3. glaucoma
4. Gilles-de-la-Tourettesyndrome
5. pheochromocytoma
6. hyperthyroid status
7. pregnancy or continued lactation
8. use of monoamine oxidase inhibitor(s) (MAOI): currently or in the past 14 days
9. treatment with other prescription psychostimulants that might potentially be effective for stimulant use disorder (i.e., (immediate release) dexamphetamine, lisdexamphetamine, methylphenidate, or modafinil)
10. anticipated need for inpatient treatment (clinical judgement)
11. (expected) inability to complete the 30 weeks study (e.g., planned holidays, expected incarceration or hospitalization)
12. insufficient command of the Dutch language
13. current participation in another addiction treatment study

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 2

1. The primary endpoint is defined as the number of days of cocaine abstinence in the final 4 weeks of treatment (i.e., weeks 21–24), assessed by combined self-report and urinalysis.
2. The key secondary endpoint is defined as "good or improved overall health status", in terms of physical health, mental health, and social functioning

Secondary endpoints 14

1. The number and proportion of patients starting and completing 24 weeks treatment
2. Maximum dose received; dose at the end of week 4; dose in final 4 weeks of study phase 1 (weeks 21–24); dose in final 4 weeks of study phase 2 (weeks 27–30)
3. Safety will be assessed and reported in terms of: Vital signs (heart rate, blood pressure) and body weight; ECG and safety laboratory parameters (NT-proBNP, and hs-Troponine); Adverse events (AEs; solicited and unsolicited) and serious adverse events (SAEs)
4. The number of days cocaine abstinence in the final 4 weeks of the discontinuation phase of the study (i.e., weeks 27–30)
5. The overall health status of patients in the final 4 weeks of the discontinuation study phase 2 (weeks 27–30), - defined as "deteriorated overall health status", in terms of physical health, mental health, and social functioning -
6. A dichotomous outcome of deterioration (yes versus no) based on the composite outcome of (1) a clinically relevant decrease of ≥5 days/month in cocaine abstinent days and/or (2) deterioration in overall health status.
7. Total number of days cocaine abstinence during first 12 weeks treatment (i.e., 0–84 days)
8. Total number of days cocaine abstinence during 24 weeks treatment (i.e., 0–168 days).
9. Complete abstinence from cocaine during 24 weeks treatment.
10. Achieving a period of sustained abstinence from cocaine for at least 21 consecutive days.
11. At least 40% reduction in cocaine use (days/month) in the final 4 weeks of treatment (weeks 21–24), compared with baseline.
12. Number of weeks of uninterrupted cocaine abstinence sustained till abstinence during final treatment week in study phase 1
13. Average number of cocaine administrations on days that cocaine was used.
14. Cocaine craving

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Placebo 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Parnassia Groep B.V.

Sponsor organisation

Parnassia Groep B.V.

Address

Monsterseweg 93

City

's-Gravenhage

Postcode

2553 RJ

Country

Netherlands

Scientific contact point

Organisation

Parnassia Groep B.V.

Contact name

Vincent Hendriks

Public contact point

Organisation

Parnassia Groep B.V.

Contact name

Vincent Hendriks

Locations

1 EU/EEA country · 3 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 29 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

5 submissions — initial application plus substantial / non-substantial modifications