Trial · NCT00809835

Galantamine to Enhance Cognitive Behavioral Therapy for Cocaine Abuse

NCT00809835, Phase 2, Completed, Yale University; results first posted 2017-06-12

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Galantamine to Enhance Cognitive Behavioral Therapy for Cocaine Abuse. Trials, record NCT00809835. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00809835

On this page

Trial

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

Title: Galantamine to Enhance Cognitive Behavioral Therapy for Cocaine Abuse
NCT number: NCT00809835
Status: Completed
Phases: Phase 2
Enrollment: 120 participants, actual
Lead sponsor: Yale University
Conditions: Cocaine Dependence
Interventions: Galantamine, Computer Assisted Cognitive Behavioral Therapy (CBT)
First posted: 2008-12-17
Last updated: 2019-01-30
Results first posted: 2017-06-12

Source ClinicalTrials.gov

Registered outcomes3

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

List	Outcome	Time frame	Description
Primary	Cocaine Use	12 weeks	Reduction in cocaine use, operationalized as the frequency of cocaine use by month using timeline followback.
Primary	Cocaine Abstinence	12 weeks	operationalized by percentage of drug-free urine specimens submitted (We will use the Branan ToxCup Drug Screen Cup onsite TESTCUP system for detection of cocaine, methamphetamine, THC, benzodiazepine, and opioids) at 12 Weeks
Secondary	Cognitive Function	12 weeks	A composite using a carefully selected neuropsychological battery that includes measures of executive cognitive functioning frequently affected among cocaine users, likely to be important moderators of CBT4CBT, and sensitive to galantamine effects. These will include measures of multiple aspects of attention, cognitive inhibition, sustained attention (CANTAB), decision making (BART), and memory (digit span). Scores ranged from -1.77 to 1.42 with a higher score indicating higher cognitive functioning.

Source ClinicalTrials.gov

Outcomes3

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Cocaine Use	12 weeks	Presented are data for those measured at baseline and at 12 weeks. 2 individuals in the Galantamine arm were not measured at 12 weeks.	Days	MEAN
PRIMARY	Cocaine Abstinence	12 weeks	Three arm had one subject drop out before study medication was given- therefore the number analyzed are those that received first treatment.	percentage of negative urines	MEAN
SECONDARY	Cognitive Function	12 weeks	All participants did not complete the CANTAB assessments at both pre and post treatment. Reasons for not completing were refusal to complete the tasks, inability to complete the tasks in a manner in which they could be scored and equipment or computer problems.	scores on a scale	MEAN

Source ClinicalTrials.gov

Results by group16

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

Outcome	Group	Category	Value	Spread	Units
Cocaine Use	Galantamine and CBT	Baseline	18.82	Standard Deviation 8.68	Days
Cocaine Use	Galantamine	Baseline	14.81	Standard Deviation 9.05	Days
Cocaine Use	Placebo and CBT	Baseline	15.68	Standard Deviation 7.78	Days
Cocaine Use	Placebo Only	Baseline	14.85	Standard Deviation 8.47	Days
Cocaine Use	Galantamine and CBT	12 Weeks	8.60	Standard Deviation 6.95	Days
Cocaine Use	Galantamine	12 Weeks	6.32	Standard Deviation 6.52	Days
Cocaine Use	Placebo and CBT	12 Weeks	7.65	Standard Deviation 7.41	Days
Cocaine Use	Placebo Only	12 Weeks	10.25	Standard Deviation 7.79	Days
Cocaine Abstinence	Galantamine and CBT		22.45	Standard Deviation 35.62	percentage of negative urines
Cocaine Abstinence	Galantamine		31.13	Standard Deviation 34.16	percentage of negative urines

1 to 10 of 16Source ClinicalTrials.gov

See all 16 results by group

Participant flow12

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

Period	Milestone	Group	Participants
Overall Study	STARTED	Galantamine and CBT	28
Overall Study	STARTED	Galantamine Only	27
Overall Study	STARTED	Placebo and CBT	38
Overall Study	STARTED	Placebo Only	27
Overall Study	COMPLETED	Galantamine and CBT	20
Overall Study	COMPLETED	Galantamine Only	20
Overall Study	COMPLETED	Placebo and CBT	27
Overall Study	COMPLETED	Placebo Only	25
Overall Study	NOT COMPLETED	Galantamine and CBT	8
Overall Study	NOT COMPLETED	Galantamine Only	7

1 to 10 of 12Source ClinicalTrials.gov

See all 12 participant flow

Adverse events72

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	Fatigue	General disorders	Galantamine and CBT	2	28	3
other	Fatigue	General disorders	Galantamine	3	27	5
other	Fatigue	General disorders	Placebo and CBT	8	38	13
other	Fatigue	General disorders	Placebo Only	4	27	7
other	agitation	General disorders	Galantamine and CBT	4	28	5
other	agitation	General disorders	Galantamine	0	27	0
other	agitation	General disorders	Placebo and CBT	3	38	3
other	agitation	General disorders	Placebo Only	1	27	1
other	headache	General disorders	Galantamine and CBT	5	28	6
other	headache	General disorders	Galantamine	6	27	8

1 to 10 of 72Source ClinicalTrials.gov

See all 72 adverse events

Adverse event totals12

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Galantamine and CBT
Total, all-cause mortality	Galantamine
Total, all-cause mortality	Placebo and CBT
Total, all-cause mortality	Placebo Only
Total, other adverse events	Galantamine and CBT	15	28
Total, other adverse events	Galantamine	10	27
Total, other adverse events	Placebo and CBT	16	38
Total, other adverse events	Placebo Only	14	27
Total, serious adverse events	Galantamine and CBT	4	28
Total, serious adverse events	Galantamine	6	27

1 to 10 of 12Source ClinicalTrials.gov

See all 12 adverse event totals

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
29286595	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
R01DA015969	Computer-based Training in Cognitive Behavioral Therapy: Web-based delivery of CB	CARROLL, KATHLEEN M.	YALE UNIVERSITY	NATIONAL INSTITUTE ON DRUG ABUSE	2002 to 2015

Source NIH RePORTER

Trial comparisons0

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

None in this release.

Tests1

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

Test	Named as
Digit Span Test	Secondary outcome

Source ConductCognition

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/NCT00809835

GET https://conductscience.org/api/trials/v1/NCT00809835/events?page=2

API reference For AI assistants