Trial · NCT00249444

Mirtazapine for Treating Cocaine Dependent Individuals Who Also Suffer From Depression

NCT00249444, Phase 2, Completed, New York State Psychiatric Institute; results first posted 2017-10-25

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Mirtazapine for Treating Cocaine Dependent Individuals Who Also Suffer From Depression. Trials, record NCT00249444. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00249444

On this page

Trial

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

Title: Mirtazapine for Treating Cocaine Dependent Individuals Who Also Suffer From Depression
NCT number: NCT00249444
Status: Completed
Phases: Phase 2
Enrollment: 86 participants, actual
Lead sponsor: New York State Psychiatric Institute
Conditions: Cocaine Dependence, Depression
Interventions: Mirtazapine, Placebo
First posted: 2005-11-07
Last updated: 2017-10-25
Results first posted: 2017-10-25
Limitations and caveats: Early cocaine responders were the most likely to achieve three weeks of continuous abstinence. 20% of patients on mirtazapine did not have any detectable blood level, therefore, poor compliance may have prevented detection of a medication effect.

Source ClinicalTrials.gov

Registered outcomes2

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

List	Outcome	Time frame	Description
Primary	Cocaine Abstinence During Last Three Weeks of Study	measured daily by self report and confimed by urine toxicology for 8 weeks of the trial or length of study participation	measured daily by self report and confimed by urine toxicology for 8 weeks of the trial or length of study participation
Primary	Depression Score on Hamilton - Depression 25 Item	End of 8 week study or last week of participation	Participants those who had a 50% decrease in HAM-D scores from baseline at end of study. The outcome measured is 50% drop in Hamilton score at week 8 or last week of study participation compared to baseline. We looked at the difference between baseline score and score at week 8 or last week of study participation.

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	Cocaine Abstinence During Last Three Weeks of Study	measured daily by self report and confimed by urine toxicology for 8 weeks of the trial or length of study participation		participants	NUMBER
PRIMARY	Depression Score on Hamilton - Depression 25 Item	End of 8 week study or last week of participation		participants	NUMBER

Source ClinicalTrials.gov

Results by group4

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

Outcome	Group	Value	Units
Cocaine Abstinence During Last Three Weeks of Study	Mirtazapine	5	participants
Cocaine Abstinence During Last Three Weeks of Study	Placebo	9	participants
Depression Score on Hamilton - Depression 25 Item	Mirtazapine	38	participants
Depression Score on Hamilton - Depression 25 Item	Placebo	42	participants

Source ClinicalTrials.gov

Participant flow6

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

Period	Milestone	Group	Participants
Overall Study	STARTED	Mirtazapine	42
Overall Study	STARTED	Placebo	44
Overall Study	COMPLETED	Mirtazapine	30
Overall Study	COMPLETED	Placebo	29
Overall Study	NOT COMPLETED	Mirtazapine	12
Overall Study	NOT COMPLETED	Placebo	15

Source ClinicalTrials.gov

Adverse events18

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	somnolence	General disorders	Mirtazapine	5	42	5
other	somnolence	General disorders	Placebo	0	44	0
other	weight gain	General disorders	Mirtazapine	9	42	9
other	weight gain	General disorders	Placebo	0	44	0
other	dizziness	General disorders	Mirtazapine	2	42	2
other	dizziness	General disorders	Placebo	1	44	1
other	restlessness	General disorders	Mirtazapine	1	42	1
other	restlessness	General disorders	Placebo	2	44	2
other	appetite increase	General disorders	Mirtazapine	5	42	5
other	appetite increase	General disorders	Placebo	0	44	0

1 to 10 of 18Source ClinicalTrials.gov

See all 18 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Mirtazapine
Total, all-cause mortality	Placebo
Total, other adverse events	Mirtazapine	20	42
Total, other adverse events	Placebo	4	44
Total, serious adverse events	Mirtazapine	2	42
Total, serious adverse events	Placebo	0	44

Source ClinicalTrials.gov

Papers0

The papers the trial lists on ClinicalTrials.gov.

None in this release.

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
P50DA009236	Novel Medication Approaches for Substance Abuse	KLEBER, HERBERT DAVID	NEW YORK STATE PSYCHIATRIC INSTITUTE DBA RESEARCH FOUNDATION FOR MENTAL HYGIENE, INC	NATIONAL INSTITUTE ON DRUG ABUSE	1994 to 2013

Source NIH RePORTER

Trial comparisons3

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison	Source
Mirtazapine vs Placebo: Cocaine Abstinence During Last Three Weeks of Study	Trial comparisons
Mirtazapine vs Placebo: Depression Score on Hamilton - Depression 25 Item	Trial comparisons
Mirtazapine vs Placebo: serious adverse events	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.

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/NCT00249444

GET https://conductscience.org/api/trials/v1/NCT00249444/registered

API reference For AI assistants