Trial · NCT00498550
Treatment of Schizophrenia and Comorbid Cannabis Use Disorder: Comparing Clozapine to Treatment-as-Usual
NCT00498550, Phase 4, Completed, Dartmouth-Hitchcock Medical Center; results first posted 2012-01-19
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Treatment of Schizophrenia and Comorbid Cannabis Use Disorder: Comparing Clozapine to Treatment-as-Usual. Trials, record NCT00498550. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00498550
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Treatment of Schizophrenia and Comorbid Cannabis Use Disorder: Comparing Clozapine to Treatment-as-Usual
- NCT number
- NCT00498550
- Status
- Completed
- Phases
- Phase 4
- Enrollment
- 31 participants, actual
- Lead sponsor
- Dartmouth-Hitchcock Medical Center
- Conditions
- Schizophrenia, Dual Diagnosis, Schizoaffective Disorder, Psychotic Disorder, Cannabis Abuse
- Interventions
- Clozapine, Treatment as usual
- First posted
- 2007-07-10
- Last updated
- 2019-03-13
- Results first posted
- 2012-01-19
Source ClinicalTrials.gov
Registered outcomes1
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Average Over Time of Intensity of Cannabis Use (Used to Evaluate Treatment Efficacy) | Week 1 to week 12 | Intensity of cannabis use is obtained for each week retrospectively as the number of joints smoked during the prior week (assessed by the Timeline Followback Scale). Mixed models are used to obtain estimates of efficacy from the partial data provided by each subject while adherent to assigned treatment (under the 'missing at random' assumption). The 'explanatory' estimands (target of the mixed model estimation) are defined in terms of population quantities that would have occurred had all subjects remained on assigned treatment throughout the study. The point estimate for each arm is reported under Number. |
Source ClinicalTrials.gov
Outcomes1
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Average Over Time of Intensity of Cannabis Use (Used to Evaluate Treatment Efficacy) | Week 1 to week 12 | Joints per week | NUMBER |
Source ClinicalTrials.gov
Results by group2
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Average Over Time of Intensity of Cannabis Use (Used to Evaluate Treatment Efficacy) | Clozapine | 0.02 | 95% Confidence Interval -2.1 to 2.5 | Joints per week | |
| Average Over Time of Intensity of Cannabis Use (Used to Evaluate Treatment Efficacy) | Treatment as Usual | 4.56 | 95% Confidence Interval -0.2 to 9.3 | Joints per week |
Source ClinicalTrials.gov
Participant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Clozapine | 15 | |
| Overall Study | STARTED | Treatment as Usual | 16 | |
| Overall Study | COMPLETED | Clozapine | 15 | |
| Overall Study | COMPLETED | Treatment as Usual | 15 | |
| Overall Study | NOT COMPLETED | Clozapine | 0 | |
| Overall Study | NOT COMPLETED | Treatment as Usual | 1 |
Source ClinicalTrials.gov
Adverse events60
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 | Agitation | Psychiatric disorders | Clozapine | 1 | 15 | 1 |
| other | Agitation | Psychiatric disorders | Treatment as Usual | 1 | 16 | 1 |
| other | Akathisia | Nervous system disorders | Clozapine | 1 | 15 | 1 |
| other | Akathisia | Nervous system disorders | Treatment as Usual | 1 | 16 | 1 |
| other | Constipation | Gastrointestinal disorders | Clozapine | 4 | 15 | 4 |
| other | Constipation | Gastrointestinal disorders | Treatment as Usual | 0 | 16 | 0 |
| other | Depression | Psychiatric disorders | Clozapine | 1 | 15 | 1 |
| other | Depression | Psychiatric disorders | Treatment as Usual | 1 | 16 | 1 |
| other | Dizziness | Nervous system disorders | Clozapine | 5 | 15 | 8 |
| other | Dizziness | Nervous system disorders | Treatment as Usual | 1 | 16 | 1 |
1 to 10 of 60Source ClinicalTrials.gov
See all 60 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Clozapine | ||
| Total, all-cause mortality | Treatment as Usual | ||
| Total, other adverse events | Clozapine | 15 | 15 |
| Total, other adverse events | Treatment as Usual | 15 | 16 |
| Total, serious adverse events | Clozapine | 4 | 15 |
| Total, serious adverse events | Treatment as Usual | 4 | 16 |
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 |
|---|---|---|---|---|---|
| R01DA013196 | CANNABIS AND SCHIZOPHRENIA: CLOZAPINE VS RISPERIDONE | GREEN, ALAN I | DARTMOUTH COLLEGE | NATIONAL INSTITUTE ON DRUG ABUSE | 2000 to 2005 |
Source NIH RePORTER
Trial comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| Clozapine vs Treatment as Usual: 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/NCT00498550
GET https://conductscience.org/api/trials/v1/NCT00498550/events?page=2