Trial · NCT05529927
Registered outcomes15
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 15 of 15
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Primary outcome measure for the primary study objective (to evaluate the efficacy of 24 weeks SR-dexamphetamine, compared with 24 weeks placebo): the number of days cocaine abstinence. | Final 4 weeks of treatment (first study phase; i.e., week 21-24) | The number of days of cocaine abstinence in the final 4 weeks of treatment, assessed by combined self-report and urinalysis. |
| Secondary | Key secondary outcome measure for the primary study objective ("good or improved overall health status", in terms of physical health, mental health, and social functioning). | Final 4 weeks of treatment (i.e. week 21 - week 24) compared with baseline | Good or improved overall health is defined as follows: * In patients with physical health problems (Maudsley Addiction Profile; MAP-HSS), or mental health problems (Brief Symptom Inventory; BSI) or problematic social functioning (Social functioning, criminality; European Addiction Severity Index; EuropASI) at baseline, good or improved overall health is defined as: at least 40% improvement in at least one of the 'problematic' health domains, compared with baseline status, assessed at week 24. * In patients without physical health problems, or mental health problems or problematic social functioning at baseline, good or improved overall health is defined as: no deterioration of 40% or more in any of the 'non-problematic' health domains, compared with baseline status, that results in crossing the threshold of health problems, again assessed at week 24. This endpoint concerns the 24-week efficacy of SR-dexamphetamine in terms of overall health. |
| Secondary | Secondary outcome measures for the primary study objective: Cocaine use related secondary endpoints: (1) Total number of days cocaine abstinence. | During first 12 weeks treatment (i.e., 0-84 days) | |
| Secondary | Secondary outcome measures for the primary study objective: Cocaine use related secondary endpoints: (2) Total number of days cocaine abstinence. | During 24 weeks treatment (i.e., 0-168 days) | |
| Secondary | Secondary outcome measures for the primary study objective: Cocaine use related secondary endpoints: (3) Complete abstinence from cocaine. | During 24 weeks treatment | |
| Secondary | Secondary outcome measures for the primary study objective: Cocaine use related endpoints: (4) Achieving a period of sustained abstinence from cocaine for at least 21 consecutive days. | During 24 weeks treatment | Proportion of subjects achieving sustained cocaine abstinence of at least 21 consecutive days as measured by the Timeline Follow-Back Method (TLFB): SR-dexamphetamine versus placebo. Higher proportion means better outcome. |
| Secondary | Secondary outcome measures for the primary study objective: Cocaine use related endpoints: (5) At least 40% reduction in cocaine use (days/month) in the final 4 weeks of treatment (weeks 21-24), compared with baseline. | The final 4 weeks of treatment (weeks 21-24) | |
| Secondary | Secondary outcome measures for the primary study objective: Cocaine use related endpoints: (6) Number of weeks of uninterrupted cocaine abstinence sustained till abstinence during final treatment week in study phase 1. | Final treatment week in study phase 1 | |
| Secondary | Secondary outcome measures for the primary study objective: Cocaine use related endpoints: (7) Average number of cocaine administrations on days that cocaine was used. | During 24 weeks treatment | |
| Secondary | Secondary outcome measures for the primary study objective: Cocaine use related endpoints: (8) Cocaine craving. | During 24 weeks treatment | Cocaine craving is measured using the Obsessive Compulsive Drug Use Scale (OCDUS, Franken et al., 2002), with a score range of 0 to 20. Higher scores mean worse outcome. |
| Secondary | Secondary outcome measure for the secondary study objective (to assess the acceptance, tolerability, and safety of 24 weeks SR-dexamphetamine): treatment completion; medication adherence; adverse events, and serious adverse events. | The first 24 weeks of treatment | * The number and proportion of patients starting and completing 24 weeks treatment; * 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) (all: mean(std.dev), and median/IQR). * 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 T). * Adverse events (AEs; solicited and unsolicited) and serious adverse events (SAEs). |
| Secondary | Secondary outcome measure for the secondary study objective (to evaluate the effect of discontinuation of SR-dexamphetamine after 24 weeks treatment): days cocaine abstinence. | Final 4 weeks of treatment discontinuation phase (second study phase; i.e., week 27-30) | Days cocaine abstinence in the final 4 weeks of the discontinuation phase of the study (i.e., weeks 27-30), assessed by combined self-report and urinalysis. A decrease of ≥5 days/month in cocaine abstinent days, compared with the number of cocaine abstinent days/month at the end of study phase 1 (weeks 21-24) is considered to be a clinically relevant deterioration. |
| Secondary | Secondary outcome measure for the secondary study objective (to evaluate the effect of discontinuation of SR-dexamphetamine after 24 weeks treatment): overall health status. | Final 4 weeks of treatment discontinuation phase (second study phase; i.e., week 27-30) | 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 - thereby using the overall health status at the end of study phase 1 (weeks 21-24) as reference. More specifically, deteriorated overall health status is defined as follows: In patients without physical health problems, or mental health problems or problematic social functioning at week 24, deteriorated overall health status is defined as: a deterioration of 40% or more in any of the 'non-problematic' health domains, compared with status at week 24, that results in crossing the threshold of health problems, assessed at week 30. |
| Secondary | Secondary outcome measure for the secondary study objective (to evaluate the effect of discontinuation of SR-dexamphetamine after 24 weeks treatment): dichotomous outcome of deterioration. | Final 4 weeks of treatment discontinuation phase (second study phase; i.e., week 27-30) | 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. |
| Other | Outcome measure for the exploratory study objective (to explore the cost-utility of 24 weeks SR-dexamphetamine treatment, compared with 24-weeks placebo): | The first 24 weeks of treatment | For this purpose, we will use the following exploratory outcomes: * QALYs. * Costs related to treatment, additional health care consumption, and criminality. |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
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