Trial · NCT05529927
Efficacy and Safety of Sustained-release Dexamphetamine in Patients With Moderate to Severe Cocaine Use Disorder
NCT05529927, Phase 2, Recruiting, Parnassia Addiction Research Centre
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Efficacy and Safety of Sustained-release Dexamphetamine in Patients With Moderate to Severe Cocaine Use Disorder. Trials, record NCT05529927. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT05529927
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Efficacy and Safety of Sustained-release Dexamphetamine in Patients With Moderate to Severe Cocaine Use Disorder
- NCT number
- NCT05529927
- Status
- Recruiting
- Phases
- Phase 2
- Enrollment
- 204 participants, estimated
- Lead sponsor
- Parnassia Addiction Research Centre
- Conditions
- Cocaine Use Disorder
- Interventions
- Sustained-release Dexamphetamine, Placebo
- First posted
- 2022-09-07
- Last updated
- 2026-05-29
Source ClinicalTrials.gov
Registered outcomes15
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| 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. |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 registered outcomesOutcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers2
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
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.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT05529927
GET https://conductscience.org/api/trials/v1/NCT05529927/registered