Trial · NCT00468143
A Within-Subject Cross-Over Comparison Between Immediate Release and Extended Release Adderall
NCT00468143, Phase 4, Completed, NYU Langone Health; results first posted 2016-06-02
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. A Within-Subject Cross-Over Comparison Between Immediate Release and Extended Release Adderall. Trials, record NCT00468143. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00468143
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Within-Subject Cross-Over Comparison Between Immediate Release and Extended Release Adderall
- NCT number
- NCT00468143
- Status
- Completed
- Phases
- Phase 4
- Enrollment
- 62 participants, actual
- Lead sponsor
- NYU Langone Health
- Conditions
- Attention Deficit Hyperactivity Disorder
- Interventions
- Adderall ® Immediate Release, Adderall XR ®
- First posted
- 2007-05-02
- Last updated
- 2016-06-02
- Results first posted
- 2016-06-02
Source ClinicalTrials.gov
Registered outcomes5
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Medication Event Monitoring System (MEMS®) Dosage Adherence | The MEMS information was noted at clinic visit 3, 4, 5, 7, 8, and 9 (over 8 weeks) | Dosage adherence (MEMSd) is the number of bottle openings divided by number of doses prescribed. Adherence was measured as ≥ 75% of the doses. The number below is the total percentage of subjects who were adherent. |
| Primary | Medication Event Monitoring System (MEMS®) Regimen Adherence | The MEMS information was noted at clinic visit 3, 4, 5, 7, 8, and 9 (over 8 weeks) | Regimen adherence (MEMSr) is a percentage of the number of days in which the complete dose regimen was taken as prescribed. Adherence was measured as complete dose regimen taken on ≥ 90% of days. The number below is the total percentage of subjects who were adherent. |
| Primary | Medication Event Monitoring System (MEMS®) Time Adherence | The MEMS information was noted at clinic visit 3, 4, 5, 7, 8, and 9 (over 8 weeks) | Time adherence (MEMSt) is the percentage of doses taken as prescribed within a specified time period. Adherence was measured as ≥ 80% of doses taken at the correct time. The number below is the percentage of subjects who were adherent. |
| Secondary | Pill Count | At clinic visit 3, 4, 5, 7, 8, and 9 (over 8 weeks) | Study staff counted unused medication at each weekly visit to yield a percentage of prescribed pills that were consumed. For each group, the number given will be the total number of consumed pills divided by total number of pill prescribed. |
| Secondary | Self Report | At clinic visit 3, 4, 5, 7, 8, and 9 (over 8 weeks) | Self-reported adherence was ascertained via retrospective self-report of daily regimen adherence. Participants were considered adherent for Adderall IR (Methamphetamine salts) if they took the first does in the morning within 30 minutes of waking, and then each subsequent dose in 5-hour intervals (within 30 minutes). For Adderall XR (Methamphetamine salts), participants were considered adherent if they took the single daily dose in the morning within 30 minutes of waking. The number given below represents the total number of self-reported adherent participants divided by the total number of participants per group, times 100 (to obtain percentage). |
Source ClinicalTrials.gov
Outcomes5
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Medication Event Monitoring System (MEMS®) Dosage Adherence | The MEMS information was noted at clinic visit 3, 4, 5, 7, 8, and 9 (over 8 weeks) | These is the total of participants who completed the study. | percentage of participants adherent | NUMBER |
| PRIMARY | Medication Event Monitoring System (MEMS®) Regimen Adherence | The MEMS information was noted at clinic visit 3, 4, 5, 7, 8, and 9 (over 8 weeks) | percentage of participants adherent | NUMBER | |
| PRIMARY | Medication Event Monitoring System (MEMS®) Time Adherence | The MEMS information was noted at clinic visit 3, 4, 5, 7, 8, and 9 (over 8 weeks) | percentage of participants adherent | NUMBER | |
| SECONDARY | Pill Count | At clinic visit 3, 4, 5, 7, 8, and 9 (over 8 weeks) | percentage of pills consumed | NUMBER | |
| SECONDARY | Self Report | At clinic visit 3, 4, 5, 7, 8, and 9 (over 8 weeks) | percentage of participants adherent | NUMBER |
Source ClinicalTrials.gov
Results by group10
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Medication Event Monitoring System (MEMS®) Dosage Adherence | Adderall IR (Methamphetamine Salts) | 42.7 | percentage of participants adherent | ||
| Medication Event Monitoring System (MEMS®) Dosage Adherence | Adderall XR (Methamphetamine Salts) | 66.2 | percentage of participants adherent | ||
| Medication Event Monitoring System (MEMS®) Regimen Adherence | Adderall IR (Methamphetamine Salts) | 2.5 | percentage of participants adherent | ||
| Medication Event Monitoring System (MEMS®) Regimen Adherence | Adderall XR (Methamphetamine Salts) | 34.4 | percentage of participants adherent | ||
| Medication Event Monitoring System (MEMS®) Time Adherence | Adderall IR (Methamphetamine Salts) | 4.5 | percentage of participants adherent | ||
| Medication Event Monitoring System (MEMS®) Time Adherence | Adderall XR (Methamphetamine Salts) | 43.7 | percentage of participants adherent | ||
| Pill Count | Adderall IR (Methamphetamine Salts) | 90.4 | percentage of pills consumed | ||
| Pill Count | Adderall XR (Methamphetamine Salts) | 96.9 | percentage of pills consumed | ||
| Self Report | Adderall IR (Methamphetamine Salts) | 92.6 | percentage of participants adherent | ||
| Self Report | Adderall XR (Methamphetamine Salts) | 98.8 | percentage of participants adherent |
Source ClinicalTrials.gov
Participant flow12
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| First Intervention (3 Weeks) | STARTED | Extended Release First | 31 | |
| First Intervention (3 Weeks) | STARTED | Immediate Release First | 31 | |
| First Intervention (3 Weeks) | COMPLETED | Extended Release First | 28 | |
| First Intervention (3 Weeks) | COMPLETED | Immediate Release First | 27 | |
| First Intervention (3 Weeks) | NOT COMPLETED | Extended Release First | 3 | |
| First Intervention (3 Weeks) | NOT COMPLETED | Immediate Release First | 4 | |
| Second Intervention (3 Weeks) | STARTED | Extended Release First | 28 | |
| Second Intervention (3 Weeks) | STARTED | Immediate Release First | 27 | |
| Second Intervention (3 Weeks) | COMPLETED | Extended Release First | 25 | |
| Second Intervention (3 Weeks) | COMPLETED | Immediate Release First | 24 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 participant flowAdverse events16
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Headache | Vascular disorders | Extended Release | 4 | 62 | 6 |
| other | Headache | Vascular disorders | Immediate Release | 11 | 62 | 11 |
| other | Insomnia | General disorders | Extended Release | 14 | 62 | 15 |
| other | Insomnia | General disorders | Immediate Release | 19 | 62 | 20 |
| other | Loss of Appetite/Anorexia | General disorders | Extended Release | 23 | 62 | 26 |
| other | Loss of Appetite/Anorexia | General disorders | Immediate Release | 5 | 62 | 7 |
| other | Anxiety | Psychiatric disorders | Extended Release | 7 | 62 | 8 |
| other | Anxiety | Psychiatric disorders | Immediate Release | 4 | 62 | 6 |
| other | Trismus | Musculoskeletal and connective tissue disorders | Extended Release | 1 | 62 | 1 |
| other | Trismus | Musculoskeletal and connective tissue disorders | Immediate Release | 2 | 62 | 2 |
1 to 10 of 16Source ClinicalTrials.gov
See all 16 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Extended Release | ||
| Total, all-cause mortality | Immediate Release | ||
| Total, other adverse events | Extended Release | 53 | 62 |
| Total, other adverse events | Immediate Release | 53 | 62 |
| Total, serious adverse events | Extended Release | 0 | 62 |
| Total, serious adverse events | Immediate Release | 0 | 62 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 21904088 | DERIVED |
Source PubMed
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 comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| Extended Release vs Immediate Release: serious adverse events |
Source Trial comparisons
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/NCT00468143
GET https://conductscience.org/api/trials/v1/NCT00468143/registered