Trial · NCT00480441

Effectiveness Study of Dronabinol and BRENDA for the Treatment of Cannabis Withdrawal

NCT00480441, Phase 2, Completed, University of Pennsylvania; results first posted 2019-07-29

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Effectiveness Study of Dronabinol and BRENDA for the Treatment of Cannabis Withdrawal. Trials, record NCT00480441. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00480441

On this page

Trial

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

Title: Effectiveness Study of Dronabinol and BRENDA for the Treatment of Cannabis Withdrawal
NCT number: NCT00480441
Status: Completed
Phases: Phase 2
Enrollment: 61 participants, actual
Lead sponsor: University of Pennsylvania
Conditions: Marijuana Dependence
Interventions: Dronabinol, BRENDA therapy, Placebo
First posted: 2007-05-31
Last updated: 2019-07-29
Results first posted: 2019-07-29

Source ClinicalTrials.gov

Registered outcomes2

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

List	Outcome	Time frame	Description
Primary	Physiological Changes in Response to Cue-induced Craving.	Baseline functional mri (fMRI), (prior to randomization)	Functional MRI brain response to cannabis vs neutral cues. Higher T values represent increased blood flow in response to cues.
Primary	Tolerability of Treatment	baseline to two years	Reports of side effects leading to discontinuation of treatment were examined in all participants.

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	Physiological Changes in Response to Cue-induced Craving.	Baseline functional mri (fMRI), (prior to randomization)	All participants who met preliminary criteria and consented to undergo medical and psychiatric screening to determine eligibility for study randomization.	T value	NUMBER
PRIMARY	Tolerability of Treatment	baseline to two years	Non-Randomized participants were not measured because they were not included in the neuroimaging study.~The only data available (summary level) is presented. Despite all good faith efforts, no access to individual data is available.	participants	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
Physiological Changes in Response to Cue-induced Craving.	All Participants		5.65		T value
Tolerability of Treatment	Placebo/Dronabinol		0		participants

Source ClinicalTrials.gov

Participant flow27

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

Period	Milestone	Group	Participants
Screening	STARTED	All Screened Participants	61
Screening	STARTED	Placebo 10mg QID	0
Screening	STARTED	Dronabinol 10mg QID	0
Screening	COMPLETED	All Screened Participants	24
Screening	COMPLETED	Placebo 10mg QID	0
Screening	COMPLETED	Dronabinol 10mg QID	0
Screening	NOT COMPLETED	All Screened Participants	37
Screening	NOT COMPLETED	Placebo 10mg QID	0
Screening	NOT COMPLETED	Dronabinol 10mg QID	0
Baseline Functional MRI	STARTED	All Screened Participants	24

1 to 10 of 27Source ClinicalTrials.gov

See all 27 participant flow

Adverse events26

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	Change in Blood Pressure	Cardiac disorders	Non-Randomized Participants	0	37	0
other	Change in Blood Pressure	Cardiac disorders	Placebo/Dronabinol	2	24	2
other	Constipation/Diarrhea/	Gastrointestinal disorders	Non-Randomized Participants	0	37	0
other	Constipation/Diarrhea/	Gastrointestinal disorders	Placebo/Dronabinol	2	24	2
other	Loss of Appetite	Gastrointestinal disorders	Non-Randomized Participants	0	37	0
other	Loss of Appetite	Gastrointestinal disorders	Placebo/Dronabinol	1	24	1
other	Nausea	Gastrointestinal disorders	Non-Randomized Participants	0	37	0
other	Nausea	Gastrointestinal disorders	Placebo/Dronabinol	2	24	2
other	Cold/Flu Like	Infections and infestations	Non-Randomized Participants	0	37	0
other	Cold/Flu Like	Infections and infestations	Placebo/Dronabinol	4	24	4

1 to 10 of 26Source ClinicalTrials.gov

See all 26 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Non-Randomized Participants	0	37
Total, all-cause mortality	Placebo/Dronabinol	0	24
Total, other adverse events	Non-Randomized Participants	0	37
Total, other adverse events	Placebo/Dronabinol	20	24
Total, serious adverse events	Non-Randomized Participants	0	37
Total, serious adverse events	Placebo/Dronabinol	0	24

Source ClinicalTrials.gov

Papers2

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as	Source
14560320	BACKGROUND	PubMed
23188041	DERIVED	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
P60DA005186	Center for Research on Improving the Treatment of Drug Abuse	O'BRIEN, CHARLES P	UNIVERSITY OF PENNSYLVANIA	NATIONAL INSTITUTE ON DRUG ABUSE	1997 to 2012

Source NIH RePORTER

Trial comparisons2

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

Comparison	Source
Non-Randomized Participants vs Placebo/Dronabinol: deaths from any cause	Trial comparisons
Non-Randomized Participants vs Placebo/Dronabinol: 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/NCT00480441

GET https://conductscience.org/api/trials/v1/NCT00480441/flow?page=2

API reference For AI assistants