Trial · NCT01020019

Combined Pharmacotherapy for Cannabis Dependency

NCT01020019, Phase 2, Phase 3, Completed, New York State Psychiatric Institute; results first posted 2016-05-11

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Combined Pharmacotherapy for Cannabis Dependency. Trials, record NCT01020019. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01020019

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Trial

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

Title: Combined Pharmacotherapy for Cannabis Dependency
NCT number: NCT01020019
Status: Completed
Phases: Phase 2, Phase 3
Enrollment: 156 participants, actual
Lead sponsor: New York State Psychiatric Institute
Conditions: Cannabis Dependence, Marijuana Dependence
Interventions: Dronabinol, Placebo, Lofexidine
First posted: 2009-11-25
Last updated: 2019-04-24
Results first posted: 2016-05-11

Source ClinicalTrials.gov

Registered outcomes1

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

List	Outcome	Time frame	Description
Primary	21 Days of Consecutive Abstinence as Measured by the Time-line Followback.	reported daily for 12 weeks/ or study participation

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	21 Days of Consecutive Abstinence as Measured by the Time-line Followback.	reported daily for 12 weeks/ or study participation		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
21 Days of Consecutive Abstinence as Measured by the Time-line Followback.	Placebo		18		participants
21 Days of Consecutive Abstinence as Measured by the Time-line Followback.	Lofexidine and Dronabinol		17		participants

Source ClinicalTrials.gov

Participant flow6

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

Period	Milestone	Group	Participants
Overall Study	STARTED	Placebo	61
Overall Study	STARTED	Lofexidine and Dronabinol	61
Overall Study	COMPLETED	Placebo	35
Overall Study	COMPLETED	Lofexidine and Dronabinol	32
Overall Study	NOT COMPLETED	Placebo	26
Overall Study	NOT COMPLETED	Lofexidine and Dronabinol	29

Source ClinicalTrials.gov

Adverse events52

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	dry mouth	General disorders	Placebo	6	61	6
other	dry mouth	General disorders	Lofexidine and Dronabinol	27	61	27
other	fatigue	General disorders	Placebo	15	61	15
other	fatigue	General disorders	Lofexidine and Dronabinol	26	61	26
other	dizzy	General disorders	Placebo	12	61	12
other	dizzy	General disorders	Lofexidine and Dronabinol	21	61	21
other	insomnia	General disorders	Placebo	13	61	13
other	insomnia	General disorders	Lofexidine and Dronabinol	13	61	13
other	intoxication	General disorders	Placebo	2	61	2
other	intoxication	General disorders	Lofexidine and Dronabinol	13	61	13

1 to 10 of 52Source ClinicalTrials.gov

See all 52 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Placebo
Total, all-cause mortality	Lofexidine and Dronabinol
Total, other adverse events	Placebo	46	61
Total, other adverse events	Lofexidine and Dronabinol	47	61
Total, serious adverse events	Placebo	1	61
Total, serious adverse events	Lofexidine and Dronabinol	1	61

Source ClinicalTrials.gov

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
29457671	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
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 comparisons2

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

Comparison	Source
Lofexidine and Dronabinol vs Placebo: 21 Days of Consecutive Abstinence as Measured by the Time-line Followback.	Trial comparisons
Lofexidine and Dronabinol 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/NCT01020019

GET https://conductscience.org/api/trials/v1/NCT01020019/events?page=2

API reference For AI assistants