Cognitive Enhancement as a Target for Cocaine Pharmacotherapy

NCT01531153, Not applicable, Completed, Yale University; results first posted 2018-10-26

Trial 11

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

Field	Value	Source
Title	Cognitive Enhancement as a Target for Cocaine Pharmacotherapy	ClinicalTrials.gov
NCT number	NCT01531153	ClinicalTrials.gov
Status	Completed	ClinicalTrials.gov
Phases	Not applicable	ClinicalTrials.gov
Enrollment	93 participants, actual	ClinicalTrials.gov
Lead sponsor	Yale University	ClinicalTrials.gov
Conditions	Addiction	ClinicalTrials.gov
Interventions	Galantamine, Placebo	ClinicalTrials.gov
First posted	2012-02-10	ClinicalTrials.gov
Last updated	2018-10-26	ClinicalTrials.gov
Results first posted	2018-10-26	ClinicalTrials.gov

Registered outcomes 17

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

List	Outcome	Time frame	Description	Source
Primary	Urine Toxicology	12 weeks	Presented are the average number of urine samples positive for cocaine over 12 weeks. This outcome was corrected from the protocol registration when the study data were entered.	ClinicalTrials.gov
Secondary	Heart Rate	once a day for up to two days over 12 Weeks	Pulse	ClinicalTrials.gov
Secondary	Blood Pressure- Systolic	2 times a week for 12 weeks	Blood Pressure is taken for safety reasons	ClinicalTrials.gov
Secondary	Blood Pressure- Diastolic	2 times a week for 12 weeks	Blood Pressure is taken for safety reasons	ClinicalTrials.gov
Secondary	CANTAB RVIP Measure: RVP A	Baseline and 12 Weeks	RVIP is a computerized measure of attention. This is given at baseline and every 4 weeks over the course of the 12-week study. RVP A' (aka RVIP A PRIME): is a signal detection measure of target sensitivity (i.e., successful response to targets and withholding of responses to non-targets). Range of 0 to 1. Higher scores are better.	ClinicalTrials.gov
Secondary	CANTAB RVIP Measure: RVP B	Baseline and 12 Weeks	RVIP is a computerized measure of attention. This is given at baseline and every 4 weeks over the course of the 12-week study. RVP B": A measure of response bias (i.e., bias towards under-responding (to targets) versus over-responding (i.e., to non-targets)) range from -1 to +1, respectively.	ClinicalTrials.gov
Secondary	CANTAB RVIP Measure: RVP FALSE ALARM	Baseline and 12 Weeks	RVIP is a computerized measure of attention. This is given at baseline and every 4 weeks over the course of the 12-week study. RVP FALSE ALARM is probability of false alarm. False alarms are responses to non-targets. Higher numbers are worse (i.e., could be seen as a measure of poor response inhibition). Scores range from 0-1 where 1 is the least desirable probablity.	ClinicalTrials.gov
Secondary	CANTAB SST- SSRT	Baseline and 12 Weeks	This is the CANTAB SST measure which evaluates response inhibition. Stop Signal Reaction Time (SSRT): The estimate of the length of time between the go stimulus and the stop stimulus at which the subject is able to successfully inhibit their response on 50% of the trials. Range of scores from 0 to 1500 (unit=milliseconds) and lower scores are 'better'.	ClinicalTrials.gov
Secondary	CANTAB SST- Median Correct	Baseline and 12 Weeks	This is the CANTAB SST measure which evaluates response inhibition. Stop Signal Reaction Time (SSRT): The estimate of the length of time between the go stimulus and the stop stimulus at which the subject is able to successfully inhibit their response on 50% of the trials. Range of scores from 0 to 1500 (unit=milliseconds) and lower scores are 'better'. Median correct is the median of response times across 'go' trials where the subject has responded on the correct button (right or left).	ClinicalTrials.gov
Secondary	CANTAB SST- SD Correct	Baseline and 12 Weeks	This is the CANTAB SST measure which evaluates response inhibition. Stop Signal Reaction Time (SSRT): The estimate of the length of time between the go stimulus and the stop stimulus at which the subject is able to successfully inhibit their response on 50% of the trials. Range of scores from 0 to 1500 (unit=milliseconds) and lower scores are 'better'. SD Correct is the standard deviation of response times across 'go' trials where the subject has responded on the correct button (right or left).	ClinicalTrials.gov
Secondary	Stroop- RT Correct Neutral	weeks 0, 4, 8, 12, 16, 24, 36	Drug Stroop Task is a computerized task which presents words either cocaine-related ('drug') words or non-drug-related ('neutral') words written in colored font. The subject is asked to press a button to indicate the color of the font as quickly and accurately as possible. The task is thought to measure attentional bias to drug-related stimuli. RT Correct Neutral is the mean response time to neutral trials where the subject pressed the correct color response.	ClinicalTrials.gov
Secondary	Stroop- RT Correct Drug	weeks 0, 4, 8, 12, 16, 24, 36	Drug Stroop Task is a computerized task which presents words either cocaine-related ('drug') words or non-drug-related ('neutral') words written in colored font. The subject is asked to press a button to indicate the color of the font as quickly and accurately as possible. The task is thought to measure attentional bias to drug-related stimuli. RT Correct Drug is the mean response time to drug trials where the subject pressed the correct color response.	ClinicalTrials.gov
Secondary	Stroop- Effect Drug Neutral Mean Correct	weeks 0, 4, 8, 12, 16, 24, 36	Drug Stroop Task is a computerized task which presents words either cocaine-related ('drug') words or non-drug-related ('neutral') words written in colored font. The subject is asked to press a button to indicate the color of the font as quickly and accurately as possible. The task is thought to measure attentional bias to drug-related stimuli. Stroop Effect is difference in response time to drug versus neutral trials (i.e., RT Correct Drug - RT Correct Neutral). A larger stroop effect is 'worse' (thought to indicate more attentional bias to drug related stimuli).	ClinicalTrials.gov
Secondary	Digit Span- LDSF	Baseline and 12 Weeks	Digit Span Task description: Orally administered (not computerized) task where subjects are read-aloud lists of digits and asked to repeat them in the same order they heard them (Forward condition). Subjects are given a pair of lists for each digit length - and given a point for each list they get entirely correct. If they get at least one out of the two correct for that length, then the researcher gives them another one of a longer length (one digit longer). If they get both wrong at a given length- that task is ended. The task is then repeated with different digit lists to recall, but they are asked to repeat them or in the reverse order that they heard them (Backward condition). Longest Digit Span Forward (LDSF) is the longest digit span a participant gets correct, in the forward condition. Higher scores are better (Scale of 0 to 9).	ClinicalTrials.gov
Secondary	Digit Span- DSF	Baseline and 12 Weeks	Digit Span Task description: Orally administered (not computerized) task where subjects are read-aloud lists of digits and asked to repeat them in the same order they heard them (Forward condition). Subjects are given a pair of lists for each digit length - and given a point for each list they get entirely correct. If they get at least one out of the two correct for that length, then the researcher gives them another one of a longer length (one digit longer). If they get both wrong at a given length- that task is ended. The task is then repeated with different digit lists to recall, but they are asked to repeat them or in the reverse order that they heard them (Backward condition). Digit Span Forward (DSF) is the number of digit span trials participants got correct in the forward condition. Higher scores are better (Scale of 0 to 14).	ClinicalTrials.gov
Secondary	Digit Span- LDSB	Baseline and 12 Weeks	Digit Span Task description: Orally administered (not computerized) task where subjects are read-aloud lists of digits and asked to repeat them in the same order they heard them (Forward condition). Subjects are given a pair of lists for each digit length - and given a point for each list they get entirely correct. If they get at least one out of the two correct for that length, then the researcher gives them another one of a longer length (one digit longer). If they get both wrong at a given length- that task is ended. The task is then repeated with different digit lists to recall, but they are asked to repeat them or in the reverse order that they heard them (Backward condition). Longest Digit Span Backward (LDSB) is the longest digit span participants got correct, in the backward condition. Higher scores are better (Scale of 0 to 8).	ClinicalTrials.gov
Secondary	Digit Span- DSB	Baseline and 12 Weeks	Digit Span Task description: Orally administered (not computerized) task where subjects are read-aloud lists of digits and asked to repeat them in the same order they heard them (Forward condition). Subjects are given a pair of lists for each digit length - and given a point for each list they get entirely correct. If they get at least one out of the two correct for that length, then the researcher gives them another one of a longer length (one digit longer). If they get both wrong at a given length- that task is ended. The task is then repeated with different digit lists to recall, but they are asked to repeat them or in the reverse order that they heard them (Backward condition). Digit Span Forward (DSB) is the number of digit span trials participants got correct in the backward condition. Higher scores are better (Scale of 0 to 14).	ClinicalTrials.gov

Outcomes 17

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

Type	Outcome	Time frame	Population	Units	Measured as	Source
PRIMARY	Urine Toxicology	12 weeks		average cocaine positive urine samples	MEAN	ClinicalTrials.gov
SECONDARY	Heart Rate	once a day for up to two days over 12 Weeks	Summary data for only those measured at each week are presented (per protocol).	beats per minute (bpm)	MEAN	ClinicalTrials.gov
SECONDARY	Blood Pressure- Systolic	2 times a week for 12 weeks	Data are reported for those that were measured at each assessment.	mmHg	MEAN	ClinicalTrials.gov
SECONDARY	Blood Pressure- Diastolic	2 times a week for 12 weeks	Data are reported for those that were measured at each assessment.	mmHg	MEAN	ClinicalTrials.gov
SECONDARY	CANTAB RVIP Measure: RVP A	Baseline and 12 Weeks	complete case analysis at 12 weeks	units on a scale	MEAN	ClinicalTrials.gov
SECONDARY	CANTAB RVIP Measure: RVP B	Baseline and 12 Weeks	complete case analysis at 12 weeks	units on a scale	MEAN	ClinicalTrials.gov
SECONDARY	CANTAB RVIP Measure: RVP FALSE ALARM	Baseline and 12 Weeks	complete case analysis at 12 weeks	units on a scale	MEAN	ClinicalTrials.gov
SECONDARY	CANTAB SST- SSRT	Baseline and 12 Weeks	Complete cases analyzed at baseline and 12 weeks.	milliseconds	MEAN	ClinicalTrials.gov
SECONDARY	CANTAB SST- Median Correct	Baseline and 12 Weeks	Complete cases analyzed at baseline and 12 weeks.	milliseconds	MEAN	ClinicalTrials.gov
SECONDARY	CANTAB SST- SD Correct	Baseline and 12 Weeks	Complete cases analyzed at baseline and 12 weeks.	milliseconds	MEAN	ClinicalTrials.gov
SECONDARY	Stroop- RT Correct Neutral	weeks 0, 4, 8, 12, 16, 24, 36	Data are reported for those that were assessed at each visit.	milliseconds	MEAN	ClinicalTrials.gov
SECONDARY	Stroop- RT Correct Drug	weeks 0, 4, 8, 12, 16, 24, 36	Data are reported for those that were assessed at each visit.	milliseconds	MEAN	ClinicalTrials.gov
SECONDARY	Stroop- Effect Drug Neutral Mean Correct	weeks 0, 4, 8, 12, 16, 24, 36	Data are reported for those that were assessed at each visit.	milliseconds	MEAN	ClinicalTrials.gov
SECONDARY	Digit Span- LDSF	Baseline and 12 Weeks	Complete cases at 12 weeks were analyzed.	units on a scale	MEAN	ClinicalTrials.gov
SECONDARY	Digit Span- DSF	Baseline and 12 Weeks	Complete cases at 12 weeks were analyzed.	units on a scale	MEAN	ClinicalTrials.gov
SECONDARY	Digit Span- LDSB	Baseline and 12 Weeks	Complete cases at 12 weeks were analyzed.	units on a scale	MEAN	ClinicalTrials.gov
SECONDARY	Digit Span- DSB	Baseline and 12 Weeks	Complete cases at 12 weeks were analyzed.	units on a scale	MEAN	ClinicalTrials.gov

Results by group 306

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

Outcome	Group	Category	Value	Spread	Units	Source
Urine Toxicology	Placebo		16.1	Standard Deviation 8.0	average cocaine positive urine samples	ClinicalTrials.gov
Urine Toxicology	Galantamine 8mg		17	Standard Deviation 9.4	average cocaine positive urine samples	ClinicalTrials.gov
Urine Toxicology	Galantamine 16mg		14.9	Standard Deviation 8.5	average cocaine positive urine samples	ClinicalTrials.gov
Heart Rate	Galantamine 8mg	Week 1	78.85	Standard Deviation 12.67	beats per minute (bpm)	ClinicalTrials.gov
Heart Rate	Galantamine 16mg	Week 1	77.76	Standard Deviation 9.24	beats per minute (bpm)	ClinicalTrials.gov
Heart Rate	Placebo	Week 1	75.01	Standard Deviation 9.31	beats per minute (bpm)	ClinicalTrials.gov
Heart Rate	Galantamine 8mg	Week 2	80.24	Standard Deviation 13.61	beats per minute (bpm)	ClinicalTrials.gov
Heart Rate	Galantamine 16mg	Week 2	79.74	Standard Deviation 10.62	beats per minute (bpm)	ClinicalTrials.gov
Heart Rate	Placebo	Week 2	77.13	Standard Deviation 10.62	beats per minute (bpm)	ClinicalTrials.gov
Heart Rate	Galantamine 8mg	Week 3	78.68	Standard Deviation 11.03	beats per minute (bpm)	ClinicalTrials.gov
Heart Rate	Galantamine 16mg	Week 3	80.42	Standard Deviation 8.15	beats per minute (bpm)	ClinicalTrials.gov
Heart Rate	Placebo	Week 3	74.98	Standard Deviation 10.86	beats per minute (bpm)	ClinicalTrials.gov
Heart Rate	Galantamine 8mg	Week 4	82.35	Standard Deviation 11.18	beats per minute (bpm)	ClinicalTrials.gov
Heart Rate	Galantamine 16mg	Week 4	77.83	Standard Deviation 7.56	beats per minute (bpm)	ClinicalTrials.gov
Heart Rate	Placebo	Week 4	74.84	Standard Deviation 8.52	beats per minute (bpm)	ClinicalTrials.gov
Heart Rate	Galantamine 8mg	Week 5	80.91	Standard Deviation 10.59	beats per minute (bpm)	ClinicalTrials.gov
Heart Rate	Galantamine 16mg	Week 5	78.82	Standard Deviation 9.25	beats per minute (bpm)	ClinicalTrials.gov
Heart Rate	Placebo	Week 5	76.72	Standard Deviation 9.68	beats per minute (bpm)	ClinicalTrials.gov
Heart Rate	Galantamine 8mg	Week 6	80.44	Standard Deviation 11.17	beats per minute (bpm)	ClinicalTrials.gov
Heart Rate	Galantamine 16mg	Week 6	75.55	Standard Deviation 10.08	beats per minute (bpm)	ClinicalTrials.gov

Participant flow 9

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

Period	Milestone	Group	Participants	Source
Overall Study	STARTED	Placebo	32	ClinicalTrials.gov
Overall Study	STARTED	Galantamine 8mg	31	ClinicalTrials.gov
Overall Study	STARTED	Galantamine 16mg	30	ClinicalTrials.gov
Overall Study	COMPLETED	Placebo	22	ClinicalTrials.gov
Overall Study	COMPLETED	Galantamine 8mg	22	ClinicalTrials.gov
Overall Study	COMPLETED	Galantamine 16mg	15	ClinicalTrials.gov
Overall Study	NOT COMPLETED	Placebo	10	ClinicalTrials.gov
Overall Study	NOT COMPLETED	Galantamine 8mg	9	ClinicalTrials.gov
Overall Study	NOT COMPLETED	Galantamine 16mg	15	ClinicalTrials.gov

Adverse events 108

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	Source
other	Confusion	Psychiatric disorders	Placebo	1	32	ClinicalTrials.gov
other	Confusion	Psychiatric disorders	Galantamine 8mg	1	31	ClinicalTrials.gov
other	Confusion	Psychiatric disorders	Galantamine 16mg	2	30	ClinicalTrials.gov
other	Hallucinations	Psychiatric disorders	Placebo	0	32	ClinicalTrials.gov
other	Hallucinations	Psychiatric disorders	Galantamine 8mg	1	31	ClinicalTrials.gov
other	Hallucinations	Psychiatric disorders	Galantamine 16mg	1	30	ClinicalTrials.gov
other	Delusions	Psychiatric disorders	Placebo	0	32	ClinicalTrials.gov
other	Delusions	Psychiatric disorders	Galantamine 8mg	0	31	ClinicalTrials.gov
other	Delusions	Psychiatric disorders	Galantamine 16mg	2	30	ClinicalTrials.gov
other	Agitation	Psychiatric disorders	Placebo	5	32	ClinicalTrials.gov
other	Agitation	Psychiatric disorders	Galantamine 8mg	3	31	ClinicalTrials.gov
other	Agitation	Psychiatric disorders	Galantamine 16mg	4	30	ClinicalTrials.gov
other	Tiredness	General disorders	Placebo	7	32	ClinicalTrials.gov
other	Tiredness	General disorders	Galantamine 8mg	6	31	ClinicalTrials.gov
other	Tiredness	General disorders	Galantamine 16mg	8	30	ClinicalTrials.gov
other	Drowsiness	General disorders	Placebo	0	32	ClinicalTrials.gov
other	Drowsiness	General disorders	Galantamine 8mg	1	31	ClinicalTrials.gov
other	Drowsiness	General disorders	Galantamine 16mg	2	30	ClinicalTrials.gov
other	Insomnia	General disorders	Placebo	5	32	ClinicalTrials.gov
other	Insomnia	General disorders	Galantamine 8mg	1	31	ClinicalTrials.gov

Adverse event totals 9

The totals the trial posted for each group.

Total	Group	Affected	At risk	Source
Total, all-cause mortality	Placebo	0	32	ClinicalTrials.gov
Total, all-cause mortality	Galantamine 8mg	0	31	ClinicalTrials.gov
Total, all-cause mortality	Galantamine 16mg	0	30	ClinicalTrials.gov
Total, other adverse events	Placebo	19	32	ClinicalTrials.gov
Total, other adverse events	Galantamine 8mg	13	31	ClinicalTrials.gov
Total, other adverse events	Galantamine 16mg	15	30	ClinicalTrials.gov
Total, serious adverse events	Placebo	0	32	ClinicalTrials.gov
Total, serious adverse events	Galantamine 8mg	0	31	ClinicalTrials.gov
Total, serious adverse events	Galantamine 16mg	0	30	ClinicalTrials.gov

Papers 0

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as	Source

Grants 1

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	Source
R01DA029577	Cognitive Enhancement as a Target for Cocaine Pharmacotherapy	SOFUOGLU, MEHMET	YALE UNIVERSITY	NATIONAL INSTITUTE ON DRUG ABUSE	2011 to 2015	NIH RePORTER

Trial comparisons 0

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

Comparison	Source

Tests 3

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	Source
Digit Span Test	Secondary outcome	ConductCognition
Stop-Signal Task	Secondary outcome	ConductCognition
Stroop Color-Word Test	Secondary outcome	ConductCognition

Source 5

Field	Value	Source
Release	trials-2026-11-12-0.4.0	ClinicalTrials.gov
Release manifest SHA-256	0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4	ClinicalTrials.gov
Registry capture	2026-11-12	ClinicalTrials.gov
Results copy, AACT	2026-03-23	ClinicalTrials.gov
NIH clinical studies file	2026-11-13	ClinicalTrials.gov

The same record as JSON

Release trials-2026-11-12-0.4.0

ClinicalTrials.gov's posted results, through CTTI's AACT: ClinicalTrials.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.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

ClinicalTrials.gov: none stated ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

NIH RePORTER's clinical studies and project files: Public domain (NIH RePORTER)