DEXAMFETAMINE SULFATE, PIRACETAM for Cocaine use disorder

Inclusion criteria

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

Exclusion criteria

• {"criterion_text":"- 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)\n- anticipated need for inpatient treatment (clinical judgement)\n- (expected) inability to complete the 30 weeks study (e.g., planned holidays, expected incarceration or hospitalization)\n- insufficient command of the Dutch language\n- current participation in another addiction treatment study\n- 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\n- glaucoma\n- Gilles-de-la-Tourettesyndrome\n- pheochromocytoma\n- hyperthyroid status\n- pregnancy or continued lactation\n- use of monoamine oxidase inhibitor(s) (MAOI): currently or in the past 14 days\n- treatment with other prescription psychostimulants that might potentially be effective for stimulant use disorder (i.e., (immediate release) dexamphetamine, lisdexamphetamine, methylphenidate, or modafinil)"}

Primary endpoints

• {"endpoint_text":"- 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.","definition_or_measurement_approach":"Assessed by combined self-report and urinalysis; defined as the number of days of cocaine abstinence in weeks 21-24."}
• {"endpoint_text":"- The key secondary endpoint is defined as \"good or improved overall health status\", in terms of physical health, mental health, and social functioning","definition_or_measurement_approach":"Defined as \"good or improved overall health status\" in terms of physical health, mental health, and social functioning (no further measurement instrument specified here)."}

Secondary endpoints

• {"endpoint_text":"- The number and proportion of patients starting and completing 24 weeks treatment","definition_or_measurement_approach":""}
• {"endpoint_text":"- 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)","definition_or_measurement_approach":""}
• {"endpoint_text":"- 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)","definition_or_measurement_approach":"Safety assessed by vital signs, body weight, ECG, laboratory parameters (NT-proBNP, hs-Troponine), AEs and SAEs."}
• {"endpoint_text":"- The number of days cocaine abstinence in the final 4 weeks of the discontinuation phase of the study (i.e., weeks 27–30)","definition_or_measurement_approach":""}
• {"endpoint_text":"- 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 -","definition_or_measurement_approach":""}
• {"endpoint_text":"- 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.","definition_or_measurement_approach":"Composite: (1) decrease of ≥5 days/month in cocaine abstinent days and/or (2) deterioration in overall health status; outcome dichotomous yes/no."}
• {"endpoint_text":"- Total number of days cocaine abstinence during first 12 weeks treatment (i.e., 0–84 days)","definition_or_measurement_approach":""}
• {"endpoint_text":"- Total number of days cocaine abstinence during 24 weeks treatment (i.e., 0–168 days).","definition_or_measurement_approach":""}
• {"endpoint_text":"- Complete abstinence from cocaine during 24 weeks treatment.","definition_or_measurement_approach":""}
• {"endpoint_text":"- Achieving a period of sustained abstinence from cocaine for at least 21 consecutive days.","definition_or_measurement_approach":""}
• {"endpoint_text":"- At least 40% reduction in cocaine use (days/month) in the final 4 weeks of treatment (weeks 21–24), compared with baseline.","definition_or_measurement_approach":""}
• {"endpoint_text":"- Number of weeks of uninterrupted cocaine abstinence sustained till abstinence during final treatment week in study phase 1","definition_or_measurement_approach":""}
• {"endpoint_text":"- Average number of cocaine administrations on days that cocaine was used.","definition_or_measurement_approach":""}
• {"endpoint_text":"- Cocaine craving","definition_or_measurement_approach":""}

Netherlands

Earliest CTIS Part Ii Submission Date

05-10-2024

Latest Decision Or Authorization Date

05-01-2026

Processing Time Days

457

Number Of Sites

3

Number Of Participants

204

Primary sponsor

Full Name

Parnassia Groep B.V.

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

Netherlands