Trial · NCT00553319

Study of Adderall-XR for the Treatment of Adult Attention Deficit Hyperactivity Disorder and Cocaine Dependence

NCT00553319, Phase 2, Phase 3, Completed, New York State Psychiatric Institute; results first posted 2014-09-01

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Study of Adderall-XR for the Treatment of Adult Attention Deficit Hyperactivity Disorder and Cocaine Dependence. Trials, record NCT00553319. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00553319

On this page

Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Study of Adderall-XR for the Treatment of Adult Attention Deficit Hyperactivity Disorder and Cocaine Dependence
NCT number: NCT00553319
Status: Completed
Phases: Phase 2, Phase 3
Enrollment: 139 participants, actual
Lead sponsor: New York State Psychiatric Institute
Conditions: Adult Attention Deficit Hyperactivity Disorder, Cocaine Dependence
Interventions: Placebo, Adderall-XR, Adderall-XR
First posted: 2007-11-05
Last updated: 2019-04-24
Results first posted: 2014-09-01
Limitations and caveats: The dropout rate was relatively low, however, there were dropouts, and this does introduce uncertainly into the outcome assessment. Since all patients received CBT we cannot conclude whether CBT is necessary to derive benefit from the medication.

Source ClinicalTrials.gov

Registered outcomes2

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Last Three Weeks of Cocaine Abstinence Based on Urine Toxicology Results and Self Reported Use	weekly for 14 weeks of trial or for length of participation	Each week after randomization was scored dichotomously as cocaine positive or negative. Cocaine use was positive if any urine or self-report was positive. Cocaine use was negative if all urines (BE \<300 ng/ml) and all self-report were negative. Weeks with no urine or no self-report were designated missing.
Primary	ADHD Symptoms Based on ADHD Rating Scale	measured once per week for 14 weeks or length of study participation	The proportion of subjects exhibiting \>30% reduction of AISRS score at last enrollment week compared to week 0

Source ClinicalTrials.gov

Outcomes2

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Last Three Weeks of Cocaine Abstinence Based on Urine Toxicology Results and Self Reported Use	weekly for 14 weeks of trial or for length of participation		percentage of participants	NUMBER
PRIMARY	ADHD Symptoms Based on ADHD Rating Scale	measured once per week for 14 weeks or length of study participation		participants	NUMBER

Source ClinicalTrials.gov

Results by group6

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Value	Units
Last Three Weeks of Cocaine Abstinence Based on Urine Toxicology Results and Self Reported Use	Placebo	7	percentage of participants
Last Three Weeks of Cocaine Abstinence Based on Urine Toxicology Results and Self Reported Use	Adderall-XR 60 mg	18	percentage of participants
Last Three Weeks of Cocaine Abstinence Based on Urine Toxicology Results and Self Reported Use	Adderall-XR 80 mg	30	percentage of participants
ADHD Symptoms Based on ADHD Rating Scale	Placebo	17	participants
ADHD Symptoms Based on ADHD Rating Scale	Adderall-XR 60 mg	30	participants
ADHD Symptoms Based on ADHD Rating Scale	Adderall-XR 80 mg	25	participants

Source ClinicalTrials.gov

Participant flow9

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Placebo	43
Overall Study	STARTED	Adderall-XR 60 mg	40
Overall Study	STARTED	Adderall-XR 80 mg	43
Overall Study	COMPLETED	Placebo	29
Overall Study	COMPLETED	Adderall-XR 60 mg	30
Overall Study	COMPLETED	Adderall-XR 80 mg	34
Overall Study	NOT COMPLETED	Placebo	14
Overall Study	NOT COMPLETED	Adderall-XR 60 mg	10
Overall Study	NOT COMPLETED	Adderall-XR 80 mg	9

Source ClinicalTrials.gov

Adverse events30

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	Anxiety	Psychiatric disorders	Placebo	3	43	3
other	Anxiety	Psychiatric disorders	Adderall-XR 60 mg	6	40	6
other	Anxiety	Psychiatric disorders	Adderall-XR 80 mg	7	43	7
other	Insomnia	General disorders	Placebo	1	43	1
other	Insomnia	General disorders	Adderall-XR 60 mg	5	40	5
other	Insomnia	General disorders	Adderall-XR 80 mg	7	43	7
other	Dry Mouth	General disorders	Placebo	0	43	0
other	Dry Mouth	General disorders	Adderall-XR 60 mg	7	40	7
other	Dry Mouth	General disorders	Adderall-XR 80 mg	5	43	5
other	Decreased Appetite	General disorders	Placebo	1	43	1

1 to 10 of 30Source ClinicalTrials.gov

See all 30 adverse events

Adverse event totals9

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Placebo
Total, all-cause mortality	Adderall-XR 60 mg
Total, all-cause mortality	Adderall-XR 80 mg
Total, other adverse events	Placebo	8	43
Total, other adverse events	Adderall-XR 60 mg	19	40
Total, other adverse events	Adderall-XR 80 mg	19	43
Total, serious adverse events	Placebo	2	43
Total, serious adverse events	Adderall-XR 60 mg	0	40
Total, serious adverse events	Adderall-XR 80 mg	0	43

Source ClinicalTrials.gov

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
25887096	DERIVED

Source PubMed

Grants1

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.

Project	Title	Principal investigators	Organization	Funder	Fiscal years
R01DA023652	Extended Release Mixed Amphetamine Salts for Adult ADHD and Cocaine Dependence	LEVIN, FRANCES RUDNICK	NEW YORK STATE PSYCHIATRIC INSTITUTE DBA RESEARCH FOUNDATION FOR MENTAL HYGIENE, INC	NATIONAL INSTITUTE ON DRUG ABUSE	2007 to 2010

Source NIH RePORTER

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.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

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/NCT00553319

GET https://conductscience.org/api/trials/v1/NCT00553319/events?page=2

API reference For AI assistants