Trial · NCT01611948

Treatment for Cannabis Withdrawal and Dependence

NCT01611948, Phase 2, Completed, The Scripps Research Institute; results first posted 2017-03-27

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Treatment for Cannabis Withdrawal and Dependence. Trials, record NCT01611948. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01611948

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Trial

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

Title: Treatment for Cannabis Withdrawal and Dependence
NCT number: NCT01611948
Status: Completed
Phases: Phase 2
Enrollment: 70 participants, actual
Lead sponsor: The Scripps Research Institute
Conditions: Cannabis Dependence
Interventions: Aprepitant, Placebo, Manual-guided behavioral counseling
First posted: 2012-06-05
Last updated: 2017-05-01
Results first posted: 2017-03-27

Source ClinicalTrials.gov

Registered outcomes1

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

List	Outcome	Time frame	Description
Primary	Change From Week 0 in Cannabis Use Using Urinary CN-THCCOOH Levels at Week 8	Week 0 and Week 8	Urinary THC/Cr ratio, also known as CN-THCCOOH (creatinine normalized tetrahydrocannabinol carboxylic acid), is a highly sensitive and specific quantitative analytic procedure to determine current marijuana metabolite levels in the urine as well as new marijuana use or abstinence. Gas chromatography mass spectrometric levels of 11-nor-9-carboxy-9-THC (THC-COOH), the primary marijuana metabolite, are normalized to the urine creatinine (CN) concentration to reduce the variability of drug measurement attributable to urine dilution. Negative values indicate decreased use. Change = (Week 8 value - Week 0 value).

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	Change From Week 0 in Cannabis Use Using Urinary CN-THCCOOH Levels at Week 8	Week 0 and Week 8	Two participants in the matched placebo arm who completed the double blind portion of the trial were unable to be analyzed for change in Urinary CN-THCCOOH Level due to missing data at Week 0 and/or Week 8. One sample was missing source documentation while the other sample was too dilute to return a reliable measurement.	ng/mg	MEAN

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
Change From Week 0 in Cannabis Use Using Urinary CN-THCCOOH Levels at Week 8	Aprepitant: 125mg/Day		-334.21	Standard Deviation 718.83	ng/mg
Change From Week 0 in Cannabis Use Using Urinary CN-THCCOOH Levels at Week 8	Matched Placebo		-359.95	Standard Deviation 1207.47	ng/mg

Source ClinicalTrials.gov

Participant flow6

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

Period	Milestone	Group	Participants
Overall Study	STARTED	Aprepitant: 125mg/Day	32
Overall Study	STARTED	Matched Placebo	38
Overall Study	COMPLETED	Aprepitant: 125mg/Day	18
Overall Study	COMPLETED	Matched Placebo	26
Overall Study	NOT COMPLETED	Aprepitant: 125mg/Day	14
Overall Study	NOT COMPLETED	Matched Placebo	12

Source ClinicalTrials.gov

Adverse events38

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
other	Consipation	Gastrointestinal disorders	Aprepitant: 125mg/Day	2	32
other	Consipation	Gastrointestinal disorders	Matched Placebo	1	38
other	Diarrhoea	Gastrointestinal disorders	Aprepitant: 125mg/Day	1	32
other	Diarrhoea	Gastrointestinal disorders	Matched Placebo	2	38
other	Dry mouth	Gastrointestinal disorders	Aprepitant: 125mg/Day	0	32
other	Dry mouth	Gastrointestinal disorders	Matched Placebo	2	38
other	Dyspepsia	Gastrointestinal disorders	Aprepitant: 125mg/Day	2	32
other	Dyspepsia	Gastrointestinal disorders	Matched Placebo	1	38
other	Nausea	Gastrointestinal disorders	Aprepitant: 125mg/Day	2	32
other	Nausea	Gastrointestinal disorders	Matched Placebo	2	38

1 to 10 of 38Source ClinicalTrials.gov

See all 38 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Aprepitant: 125mg/Day
Total, all-cause mortality	Matched Placebo
Total, other adverse events	Aprepitant: 125mg/Day	20	32
Total, other adverse events	Matched Placebo	28	38
Total, serious adverse events	Aprepitant: 125mg/Day	0	32
Total, serious adverse events	Matched Placebo	0	38

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
R01DA030988	Pharmacological Treatment of Cannabis Withdrawal and Dependence	MASON, BARBARA J	SCRIPPS RESEARCH INSTITUTE, THE	NATIONAL INSTITUTE ON DRUG ABUSE	2010 to 2015

Source NIH RePORTER

Trial comparisons1

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

Comparison
Aprepitant: 125mg/Day vs Matched Placebo: 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.

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/NCT01611948

GET https://conductscience.org/api/trials/v1/NCT01611948/events?page=2

API reference For AI assistants