Trial · NCT01821560

Baclofen Effects in Cigarette Smokers

NCT01821560, Phase 2, Completed, University of Pennsylvania; results first posted 2018-12-19

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Baclofen Effects in Cigarette Smokers. Trials, record NCT01821560. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01821560

On this page

Trial

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

Title: Baclofen Effects in Cigarette Smokers
NCT number: NCT01821560
Status: Completed
Phases: Phase 2
Enrollment: 44 participants, actual
Lead sponsor: University of Pennsylvania
Conditions: Nicotine Dependence
Interventions: Baclofen, placebo
First posted: 2013-04-01
Last updated: 2018-12-19
Results first posted: 2018-12-19
Limitations and caveats: The goals of the study were to identify mechanisms of baclofen's effects on smoking cue reactivity. Using other mechanisms we provided a treatment arm. Sample size was small.

Source ClinicalTrials.gov

Registered outcomes1

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

List	Outcome	Time frame	Description
Primary	Cigarettes Smoked Per Day	3 weeks (Scan Day 1, week1- Scan Day 2, week 4)	Cigarettes per day at Scan Day 2; Baclofen group vs. placebo group

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	Cigarettes Smoked Per Day	3 weeks (Scan Day 1, week1- Scan Day 2, week 4)		Cigarettes per day	MEAN

Source ClinicalTrials.gov

Results by group4

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

Outcome	Group	Category	Value	Spread	Units
Cigarettes Smoked Per Day	Sugar Pill	Scan Day 1	14.19	Standard Error 1.01	Cigarettes per day
Cigarettes Smoked Per Day	Baclofen	Scan Day 1	14.23	Standard Error 1.20	Cigarettes per day
Cigarettes Smoked Per Day	Sugar Pill	Scan Day 2	7.67	Standard Error 1.05	Cigarettes per day
Cigarettes Smoked Per Day	Baclofen	Scan Day 2	7.76	Standard Error 1.10	Cigarettes per day

Source ClinicalTrials.gov

Participant flow6

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

Period	Milestone	Group	Participants
Overall Study	STARTED	Sugar Pill	22
Overall Study	STARTED	Baclofen	22
Overall Study	COMPLETED	Sugar Pill	16
Overall Study	COMPLETED	Baclofen	15
Overall Study	NOT COMPLETED	Sugar Pill	6
Overall Study	NOT COMPLETED	Baclofen	7

Source ClinicalTrials.gov

Adverse events20

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	Drowsiness	Nervous system disorders	Sugar Pill	6	22
other	Drowsiness	Nervous system disorders	Baclofen	9	22
other	Nausea	Gastrointestinal disorders	Sugar Pill	1	22
other	Nausea	Gastrointestinal disorders	Baclofen	4	22
other	Headache	Nervous system disorders	Sugar Pill	4	22
other	Headache	Nervous system disorders	Baclofen	2	22
other	Dizzy/Lightheadedness	Nervous system disorders	Sugar Pill	1	22
other	Dizzy/Lightheadedness	Nervous system disorders	Baclofen	5	22
other	Insomnia	Nervous system disorders	Sugar Pill	1	22
other	Insomnia	Nervous system disorders	Baclofen	2	22

1 to 10 of 20Source ClinicalTrials.gov

See all 20 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Sugar Pill	0	22
Total, all-cause mortality	Baclofen	0	22
Total, other adverse events	Sugar Pill	17	22
Total, other adverse events	Baclofen	16	22
Total, serious adverse events	Sugar Pill	0	22
Total, serious adverse events	Baclofen	0	22

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
R01DA030394	GABA B agonists revisited: Brain, behavioral and genetic effects in smokers	FRANKLIN, TERESA R	UNIVERSITY OF PENNSYLVANIA	NATIONAL INSTITUTE ON DRUG ABUSE	2012 to 2016

Source NIH RePORTER

Trial comparisons2

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

Comparison	Source
Sugar Pill vs Baclofen: deaths from any cause	Trial comparisons
Sugar Pill vs Baclofen: 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/NCT01821560

GET https://conductscience.org/api/trials/v1/NCT01821560/registered

API reference For AI assistants