Cocaine AbuseNCT00606801

Galantamine Effects on Cognitive Function in Abstinent Cocaine Users

A study testing Galantamine in people with Cocaine Abuse, run by Yale University at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

Who is it for?: Ages 21 to 50 years
Conditions the study is for: Cocaine Abuse
What is being tested?: Galantamine
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 34 participants
Where: 1 siteUnited States
Study dates: Jun 2007to Feb 2009
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 21 to 50 years
All sexes
No healthy volunteers
Adult

Who may be able to join

Male and females, between the ages 21 and 50
Fulfill criteria for past cocaine dependence
No cocaine use for the past 30 days
No other current dependence or abuse of other drugs or alcohol
No current medical problems and normal ECG
Not pregnant,nor breast feeding,
Using acceptable birth control methods.

Who cannot join

Current major psychiatric illness including mood, psychotic or anxiety disorders
History of major medical illnesses; including asthma or chronic obstructive lung disease, history or current gastrointestinal ulcer, hepatic or renal impairment and cardiac rhythm disturbances
Use of other medications including,drugs that slow heart rate
Known allergy to galantamine

Trial locations and contacts

1 site in 1 country.

United States1 site

Veterans Affairs Hospital
West Haven, Connecticut, 06516

Other trials in United States

About this study

To evaluate galantamine's effects on cognitive performance in abstinent cocaine users. Galantamine, a medication approved for treatment of Alzheimer's disease, is an acetylcholine esterase inhibitor. Galantamine also directly potentiates nicotine receptors. Both of these effects may result in improved cognitive performance in a group of subjects known to have impaired performance in various cognitive tasks.

Read the detailed description

Galantamine, compared to placebo, will improve cognitive performance in abstinent cocaine users. The cognitive performance will be measured with the Stroop test and 3 Cambridge Neuropsychological Test Automated Battery (CANTAB) tests: Paired Associate Learning (PAL), Delayed Pattern Recognition Memory (PRM),and Rapid Visual Information Processing (RVIP). Performance on these tests has been shown to be impaired in abstinent cocaine users, compared to healthy controls.

Galantamine, compared to placebo, will not be associated with any significant changes in mood. Monitoring of mood will be achieved with 3 mood scales: 1) Center for Epidemiologic Studies Depression (CES-D) scale, Positive and Negative Affect Schedule (PANAS) and the Profile of Mood States (POMS).

Currently this study is completed, Patients are no longer being enrolled. There were 28 completers. This study has been published.

Conditions: Cocaine Abuse
Being tested: Galantamine, placebo
Keywords: cognitive enhancers, Nootropic Agents
Medical subject headings: Cocaine-Related Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

GalantamineDrug
Also called Nivalin,, Razadyne,, Razadyne ER,, Reminyl,
Galantamine 8 mg/day
placeboDrug
Also called Sugar Pill
sugar pill

Study groups in NCT00606801
Study group	Role	What they receive
Galantamine 8 mg/day	Active comparator	Galantamine 8 mg/day Receives: Drug: Galantamine
Placebo	Placebo comparator	placebo Receives: Drug: placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

Performance on the Cambridge Neuropsychological Test Automated Battery (CANTAB) - RVIP Reaction Time
Rapid Visual Processing test (RVIP) is a measure of sustained attention with a small working memory component that is sensitive to cholinergic enhancers. In the RVIP, subjects must detect either odd or even 3 digit sequences appearing in a box in a pseudo-random order at 100 digits per minute. Reaction time (RT) to correct answers was measured.
Measured: Baseline, Day 5 and Day 10
Performance on the Cambridge Neuropsychological Test Automated Battery (CANTAB) - RVIP Total Hits
Rapid Visual Processing test (RVIP) is a measure of sustained attention with a small working memory component that is sensitive to cholinergic enhancers. In the RVIP, subjects must detect either odd or even 3 digit sequences appearing in a box in a pseudo-random order at 100 digits per minute. The total hits were measured
Measured: Baseline, Day 5 and Day 10
Performance on the Cambridge Neuropsychological Test Automated Battery (CANTAB) - RVIP Total Correct Rejections
Rapid Visual Processing test (RVIP) is a measure of sustained attention with a small working memory component that is sensitive to cholinergic enhancers. In the RVIP, subjects must detect either odd or even 3 digit sequences appearing in a box in a pseudo-random order at 100 digits per minute. The number of correct rejections was measured.
Measured: Baseline, Day 5 and Day 10
Performance on the Cambridge Neuropsychological Test Automated Battery (CANTAB) - RVIP A' (Sensitivity to Target Sequences)
Rapid Visual Processing test (RVIP) is a measure of sustained attention with a small working memory component that is sensitive to cholinergic enhancers. In the RVIP, subjects must detect either odd or even 3 digit sequences appearing in a box in a pseudo-random order at 100 digits per minute. A' is a measure of sensitivity to target sequences and it reflects probabilities of hits and false alarms to provide a score of sensitivity to the target regardless of response tendency. The scores range from 0 (bad) to 1 (good).
Measured: Baseline, Day 5 and Day 10
Performance on the Cambridge Neuropsychological Test Automated Battery (CANTAB) - RVIP B' (Strength to Detect to Target Sequences)
Rapid Visual Processing test (RVIP) is a measure of sustained attention with a small working memory component that is sensitive to cholinergic enhancers. In the RVIP, subjects must detect either odd or even 3 digit sequences appearing in a box in a pseudo-random order at 100 digits per minute. B reflects the probability of hits and false alarms to provide a measure of the participants tendency to respond regardless of whether the target sequence is presented. The scores range from -1 to +1 with scores near +1 indicative of a subject that gave few false alarms.
Measured: Baseline, Day 5 and Day 10
Paired Associate Learning (PAL) - Stages Complete
Rapid Visual Processing test (RVIP) is a measure of sustained attention with a small working memory component that is sensitive to cholinergic enhancers. In the Paired Associate Learning (PAL) task, boxes are displayed on the screen and are opened in a random order. One or more of the boxes will contain a pattern. After the subjects have seen the patterns behind each box, the patterns are then displayed in the middle of the screen, one at a time, and the subject must touch the box where the pattern was originally located. An error will cause the test to open the boxes again to remind the subject of their locations. The number of boxes with patterns increases throughout the test. The stages completed and number of errors are measures of interest.
Measured: Baseline, Day 5 and Day 10
Paired Associate Learning (PAL) - Mean Errors
Rapid Visual Processing test (RVIP) is a measure of sustained attention with a small working memory component that is sensitive to cholinergic enhancers. In the Paired Associate Learning (PAL) task, boxes are displayed on the screen and are opened in a random order. One or more of the boxes will contain a pattern. After the subjects have seen the patterns behind each box, the patterns are then displayed in the middle of the screen, one at a time, and the subject must touch the box where the pattern was originally located. An error will cause the test to open the boxes again to remind the subject of their locations. The number of boxes with patterns increases throughout the test. The stages completed and number of errors are measures of interest.
Measured: Baseline, Day 5 and Day 10
Pattern Recognition Memory (PRM) - Response Time for Correct Answers
In the PRM, the subject is presented with a series of 12 visual patterns, one at a time, in the center of the screen. These patterns are designed so that they cannot easily be given verbal labels. In the recognition phase, the subject is required to choose between a pattern they have already seen and a novel pattern. The time to correct answer was measured.
Measured: Baseline, Day 5 and Day 10
Pattern Recognition Memory (PRM) - Number Correct Answers
Pattern Recognition Memory (PRM) tests visual pattern recognition memory in a two choice forced discrimination paradigm. 12 visual patterns are presented, then the subject must choose between each of these patterns and a novel pattern. The number of correct responses are measured.
Measured: Baseline, Day 5 and Day 10

Secondary outcomes (6)

Performance on the Sustained Attention to Response Task (SART) - Number of Errors on NoGo Trials
The SART is a Go / NoGo task measuring the ability to activate or inhibit responses. In this 4.5 minute task, 225 single digits (25 × 9 digits) were presented on a computer monitor. Each digit was presented for 250 ms, and was immediately followed by a mask for 900 ms. The mask consists of a ring with a diagonal cross in the center. Subjects were instructed to press a spacebar to every digit except the 3, and to give equal importance to speed and accuracy. Responses were allowed during the presentation of both the digit and mask. The digits were presented in a different random order for each subject. There were 18 practice trials, containing 2 no-response targets (3s). For the Go/NoGo task, response inhibition was measured as the number of errors on the no- Go trials, with low errors indicating better response inhibition.
Complete data for 3 subjects in the Placebo group, and for 1 subject in the galantamine group were not capture do to experimenter and computer errors.
Measured: Baseline, Day 5 and Day 10
Performance on the Sustained Attention to Response Task (SART)- Number of Errors on Go Trials
The SART is a Go / NoGo task measuring the ability to activate or inhibit responses. In this 4.5 minute task, 225 single digits (25 × 9 digits) were presented on a computer monitor. Each digit was presented for 250 ms, and was immediately followed by a mask for 900 ms. The mask consists of a ring with a diagonal cross in the center. Subjects were instructed to press a spacebar to every digit except the 3, and to give equal importance to speed and accuracy. Responses were allowed during the presentation of both the digit and mask. The digits were presented in a different random order for each subject. There were 18 practice trials, containing 2 no-response targets (3s). The number of errors on Go trials reflected the response activation function, with fewer errors indicating greater response activation.
Complete data for 3 subjects in the Placebo group, and for 1 subject in the galantamine group were not capture do to experimenter and computer errors.
Measured: Baseline, Day 5 and Day 10
Performance on the Sustained Attention to Response Task (SART)- Mean Reaction Time for Correct Press on Go Trial
The SART is a Go / NoGo task measuring the ability to activate or inhibit responses. In this 4.5 minute task, 225 single digits (25 × 9 digits) were presented on a computer monitor. Each digit was presented for 250 ms, and was immediately followed by a mask for 900 ms. The mask consists of a ring with a diagonal cross in the center. Subjects were instructed to press a spacebar to every digit except the 3, and to give equal importance to speed and accuracy. Responses were allowed during the presentation of both the digit and mask. The digits were presented in a different random order for each subject. There were 18 practice trials, containing 2 no-response targets (3s).
For the Go trial, the reaction time reflected the response activation function, faster reaction time indicating greater response activation.
Complete data for 3 subjects in the Placebo group, and for 1 subject in the galantamine group were not capture do to experimenter and computer errors.
Measured: Baseline, Day 5 and Day 10
Performance on the Modified Stroop Task (Cocaine-Stroop)- Reaction Time
The Cocaine-Stroop task measures attention capture (attentional bias) secondary to cocaine cues; (Stroop effect - calculated as the difference between mean RT on cocaine words and mean RT on control words). Subjects completed 2 counterbalanced blocks (150 trials per block). One block contained 15 cocaine words and neutral words in a mixed order. The other block contained 15 control words matched in length and frequency to cocaine words, and a different set of neutral words. Subjects were required to indicate the colors in which the words were written as quickly and accurately as possible. Reaction times for identification of word color was measured. In addition, the difference in RT to words following cocaine and control words were measured (carry-over effect). Complete data for 3 participants (2 placebo and 1 galantamine) were not capture due to experimenter and computer errors.
Measured: Baseline, Day 5 and Day 10
Performance on the Modified Stroop Task (Cocaine-Stroop)- Stroop Effect
The Cocaine-Stroop task measures attention capture (attentional bias) secondary to cocaine cues; (Stroop effect - calculated as the difference between mean RT on cocaine words and mean RT on control words). Subjects completed 2 counterbalanced blocks (150 trials per block). One block contained 15 cocaine words and neutral words in a mixed order. The other block contained 15 control words matched in length and frequency to cocaine words, and a different set of neutral words. Subjects were required to indicate the colors in which the words were written as quickly and accurately as possible. Reaction times for identification of word color was measured. In addition, the difference in RT to words following cocaine and control words were measured (carry-over effect). Complete data for 3 participants (2 placebo and 1 galantamine) were not capture due to experimenter and computer errors.
Measured: Baseline, Day 5 and Day 10
Performance on the Modified Stroop Task (Cocaine-Stroop)- Carry-over Effect
The Cocaine-Stroop task measures attention capture (attentional bias) secondary to cocaine cues; (Stroop effect - calculated as the difference between mean RT on cocaine words and mean RT on control words). Subjects completed 2 counterbalanced blocks (150 trials per block). One block contained 15 cocaine words and neutral words in a mixed order. The other block contained 15 control words matched in length and frequency to cocaine words, and a different set of neutral words. Subjects were required to indicate the colors in which the words were written as quickly and accurately as possible. Reaction times for identification of word color was measured. In addition, the difference in RT to words following cocaine and control words were measured (carry-over effect). Complete data for 3 participants (2 placebo and 1 galantamine) were not capture due to experimenter and computer errors.
Measured: Baseline, Day 5 and Day 10

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jun 2007Feb 2009

First posted5 Feb 2008 (estimated)
Study startJun 2007
Primary completionFeb 2009
Study completionFeb 2009

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Cocaine AbuseStudies of the same condition, open and under way.
More trials run by Yale UniversityThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 34 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00606801
Sponsor's protocol ID: 0706002768
Other IDs: P50DA009241, B Rounsaville
Status last verified: Feb 2021
First submitted: 23 Jan 2008
Last updated: 15 Mar 2021
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Not yet recruiting
QAIAx - SGI/SI Smart Health Cities: Microcity Enclave Program (Quantum SI/AGI Agency a/k/a AI City Hall Project - UPSTO App Nos. 64/074,526, 64/063,557, 64/105,164, 63/903,181, 63/729,428, 64/125,360; USPTO EO 9424 Assignment ID: 2101042 / ARN: REEL/FRAME: 76481/0026 - OUSD-R&E, Department of War)
Asperger's Disorder, Asperger Disorder
Recruiting
Harm Reduction Services
Drug Use, Substance Abuse
RecruitingPhase 4
Efficacy of Clonidine in Reducing Craving in Inpatients With Cocaine and Crack Use Disorder
Cocaine Use Disorder, Crack Abuse or Dependence
Recruiting
Smartphone Services for Stimulant Use Disorder
Stimulant Use Disorder

All Cocaine Abuse trials

Study at a glance

From the registry record, last updated by the sponsor on 15 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Galantamine Effects on Cognitive Function in Abstinent Cocaine Users
ClinicalTrials.gov ID: NCT00606801
Acronym / sponsor ID: 0706002768
Conditions: Cocaine Abuse
Keywords: cognitive enhancers, Nootropic Agents
Study type: Interventional
Recruitment status: Completed
Enrolment: 34 participants (actual)
Lead sponsor: Yale UniversityUniversity, hospital or other
Collaborators: National Institute on Drug Abuse (NIDA)
Study start: Jun 2007
Primary completion: Feb 2009 (actual)
Study completion: Feb 2009 (actual)
First posted: 5 Feb 2008 (estimated)
Results: Posted 31 Jul 2013

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Currently this study is completed, Patients are no longer being enrolled. There were 28 completers. This study has been published.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 2

Arm	Type	Receives
Galantamine 8 mg/day	Active comparator	Drug: GalantamineGalantamine 8 mg/day
Placebo	Placebo comparator	Drug: placeboplacebo

Who may qualify

Ages: 21 to 50 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult

Key inclusion criteria (7 listed)

Male and females, between the ages 21 and 50
Fulfill criteria for past cocaine dependence
No cocaine use for the past 30 days
No other current dependence or abuse of other drugs or alcohol
No current medical problems and normal ECG

Key exclusion criteria (4 listed)

Current major psychiatric illness including mood, psychotic or anxiety disorders
History of major medical illnesses; including asthma or chronic obstructive lung disease, history or current gastrointestinal ulcer, hepatic or renal impairment and cardiac rhythm disturbances
Use of other medications including,drugs that slow heart rate
Known allergy to galantamine

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
GalantamineAlso: Nivalin,, Razadyne,, Razadyne ER,, Reminyl,Galantamine 8 mg/day	Drug	Galantamine 8 mg/day
placeboAlso: Sugar Pillsugar pill	Drug	Placebo

Primary outcome

Performance on the Cambridge Neuropsychological Test Automated Battery (CANTAB) - RVIP Reaction Time
Time frame: Baseline, Day 5 and Day 10
Rapid Visual Processing test (RVIP) is a measure of sustained attention with a small working memory component that is sensitive to cholinergic enhancers. In the RVIP, subjects must detect either odd or even 3 digit sequences appearing in a box in a pseudo-random order at 100 digits per minute. Reaction time (RT) to correct answers was measured.
Performance on the Cambridge Neuropsychological Test Automated Battery (CANTAB) - RVIP Total Hits
Time frame: Baseline, Day 5 and Day 10
Rapid Visual Processing test (RVIP) is a measure of sustained attention with a small working memory component that is sensitive to cholinergic enhancers. In the RVIP, subjects must detect either odd or even 3 digit sequences appearing in a box in a pseudo-random order at 100 digits per minute. The total hits were measured
Performance on the Cambridge Neuropsychological Test Automated Battery (CANTAB) - RVIP Total Correct Rejections
Time frame: Baseline, Day 5 and Day 10
Rapid Visual Processing test (RVIP) is a measure of sustained attention with a small working memory component that is sensitive to cholinergic enhancers. In the RVIP, subjects must detect either odd or even 3 digit sequences appearing in a box in a pseudo-random order at 100 digits per minute. The number of correct rejections was measured.
Performance on the Cambridge Neuropsychological Test Automated Battery (CANTAB) - RVIP A' (Sensitivity to Target Sequences)
Time frame: Baseline, Day 5 and Day 10
Rapid Visual Processing test (RVIP) is a measure of sustained attention with a small working memory component that is sensitive to cholinergic enhancers. In the RVIP, subjects must detect either odd or even 3 digit sequences appearing in a box in a pseudo-random order at 100 digits per minute. A' is a measure of sensitivity to target sequences and it reflects probabilities of hits and false alarms to provide a score of sensitivity to the target regardless of response tendency. The scores range from 0 (bad) to 1 (good).
Performance on the Cambridge Neuropsychological Test Automated Battery (CANTAB) - RVIP B' (Strength to Detect to Target Sequences)
Time frame: Baseline, Day 5 and Day 10
Rapid Visual Processing test (RVIP) is a measure of sustained attention with a small working memory component that is sensitive to cholinergic enhancers. In the RVIP, subjects must detect either odd or even 3 digit sequences appearing in a box in a pseudo-random order at 100 digits per minute. B reflects the probability of hits and false alarms to provide a measure of the participants tendency to respond regardless of whether the target sequence is presented. The scores range from -1 to +1 with scores near +1 indicative of a subject that gave few false alarms.
Paired Associate Learning (PAL) - Stages Complete
Time frame: Baseline, Day 5 and Day 10
Rapid Visual Processing test (RVIP) is a measure of sustained attention with a small working memory component that is sensitive to cholinergic enhancers. In the Paired Associate Learning (PAL) task, boxes are displayed on the screen and are opened in a random order. One or more of the boxes will contain a pattern. After the subjects have seen the patterns behind each box, the patterns are then displayed in the middle of the screen, one at a time, and the subject must touch the box where the pattern was originally located. An error will cause the test to open the boxes again to remind the subject of their locations. The number of boxes with patterns increases throughout the test. The stages completed and number of errors are measures of interest.
Paired Associate Learning (PAL) - Mean Errors
Time frame: Baseline, Day 5 and Day 10
Rapid Visual Processing test (RVIP) is a measure of sustained attention with a small working memory component that is sensitive to cholinergic enhancers. In the Paired Associate Learning (PAL) task, boxes are displayed on the screen and are opened in a random order. One or more of the boxes will contain a pattern. After the subjects have seen the patterns behind each box, the patterns are then displayed in the middle of the screen, one at a time, and the subject must touch the box where the pattern was originally located. An error will cause the test to open the boxes again to remind the subject of their locations. The number of boxes with patterns increases throughout the test. The stages completed and number of errors are measures of interest.
Pattern Recognition Memory (PRM) - Response Time for Correct Answers
Time frame: Baseline, Day 5 and Day 10
In the PRM, the subject is presented with a series of 12 visual patterns, one at a time, in the center of the screen. These patterns are designed so that they cannot easily be given verbal labels. In the recognition phase, the subject is required to choose between a pattern they have already seen and a novel pattern. The time to correct answer was measured.
Pattern Recognition Memory (PRM) - Number Correct Answers
Time frame: Baseline, Day 5 and Day 10
Pattern Recognition Memory (PRM) tests visual pattern recognition memory in a two choice forced discrimination paradigm. 12 visual patterns are presented, then the subject must choose between each of these patterns and a novel pattern. The number of correct responses are measured.

6 secondary outcomes

Performance on the Sustained Attention to Response Task (SART) - Number of Errors on NoGo Trials
Time frame: Baseline, Day 5 and Day 10
Performance on the Sustained Attention to Response Task (SART)- Number of Errors on Go Trials
Time frame: Baseline, Day 5 and Day 10
Performance on the Sustained Attention to Response Task (SART)- Mean Reaction Time for Correct Press on Go Trial
Time frame: Baseline, Day 5 and Day 10
Performance on the Modified Stroop Task (Cocaine-Stroop)- Reaction Time
Time frame: Baseline, Day 5 and Day 10
Performance on the Modified Stroop Task (Cocaine-Stroop)- Stroop Effect
Time frame: Baseline, Day 5 and Day 10
Performance on the Modified Stroop Task (Cocaine-Stroop)- Carry-over Effect
Time frame: Baseline, Day 5 and Day 10

Results and safety

Results posted to the registry on 31 Jul 2013, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Placebo	17	17
Galantamine 8 mg/Day	17	17

Primary outcome: Performance on the Cambridge Neuropsychological Test Automated Battery (CANTAB) - RVIP Reaction Time

Time frame: Baseline, Day 5 and Day 10. Mean (Standard Deviation). Unit: milliseconds

Measure	Placebo n = 14	Galantamine n = 13
Baseline	407.7 (92.3)	476.8 (119.3)
Day 5	427.4 (35.3)	379.2 (71.7)
Day 10	433.3 (123.6)	386.9 (82.9)

Placebo vs Galantamine: p = 0.006, Mixed Models Analysis

Population analysed: There were a total of 28 completers, 14 for each treatment group. However, CANTAB data was not stored on the hard drive for one subject in the Galantamine group.

Primary outcome: Performance on the Cambridge Neuropsychological Test Automated Battery (CANTAB) - RVIP Total Hits

Time frame: Baseline, Day 5 and Day 10. Mean (Standard Deviation). Unit: hits

Measure	Placebo n = 14	Galantamine n = 13
Baseline	16.7 (3.6)	14.8 (4.7)
Day 5	18.0 (5.0)	16.9 (5.4)
Day 10	18.0 (6.8)	19.7 (4.3)

Placebo: p = 0.04, Mixed Models Analysis

Population analysed: There were a total of 28 completers, 14 for each treatment group. However, CANTAB data was not stored on the hard drive for one subject in the Galantamine group.

Primary outcome: Performance on the Cambridge Neuropsychological Test Automated Battery (CANTAB) - RVIP Total Correct Rejections

Time frame: Baseline, Day 5 and Day 10. Mean (Standard Deviation). Unit: correct rejections

Measure	Placebo n = 14	Galantamine n = 13
Baseline	247.2 (13.7)	242.4 (15.5)
Day 5	217.6 (16.9)	247.9 (12.9)
Day 10	248.2 (23.7)	253.9 (12.6)

Placebo vs Galantamine: p = 0.02, Mixed Models Analysis

Population analysed: There were a total of 28 completers, 14 for each treatment group. However, CANTAB data was not stored on the hard drive for one subject in the Galantamine group.

Primary outcome: Performance on the Cambridge Neuropsychological Test Automated Battery (CANTAB) - RVIP A' (Sensitivity to Target Sequences)

Time frame: Baseline, Day 5 and Day 10. Mean (Standard Deviation). Unit: sensitivity index

Measure	Placebo n = 14	Galantamine n = 13
Baseline	0.89 (0.04)	0.87 (0.07)
Day 5	0.90 (0.07)	0.90 (0.07)
Day 10	0.90 (0.10)	0.92 (0.04)

Placebo: p = 0.03, Mixed Models Analysis

Population analysed: There were a total of 28 completers, 14 for each treatment group. However, CANTAB data was not stored on the hard drive for one subject in the Galantamine group.

6 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Galantamine 8 mg/Day	0 of 17 (0%)	0 of 17 (0%)	Not reported
Placebo	0 of 17 (0%)	0 of 17 (0%)	Not reported

Limitations and caveats (from the sponsor): Relatively low medication dose and short duration of treatment. Multiple cognitive tests and outcome measures increase probability of Type 1 errors. Absence of non-addicted controls limits determination of a unique effect in abstinent users.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 15 Mar 2021.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Cocaine Abuse

Not yet recruiting
QAIAx - SGI/SI Smart Health Cities: Microcity Enclave Program (Quantum SI/AGI Agency a/k/a AI City Hall Project - UPSTO App Nos. 64/074,526, 64/063,557, 64/105,164, 63/903,181, 63/729,428, 64/125,360; USPTO EO 9424 Assignment ID: 2101042 / ARN: REEL/FRAME: 76481/0026 - OUSD-R&E, Department of War)
Asperger's Disorder, Asperger Disorder
Recruiting
Harm Reduction Services
Drug Use, Substance Abuse
RecruitingPhase 4
Efficacy of Clonidine in Reducing Craving in Inpatients With Cocaine and Crack Use Disorder
Cocaine Use Disorder, Crack Abuse or Dependence
Recruiting
Smartphone Services for Stimulant Use Disorder
Stimulant Use Disorder

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Mehmet Sofuoglu, M.D., Ph.D. principal investigator

Yale University Associate Professor

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Galantamine in people with Cocaine Abuse, run by Yale University at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 15 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 31 Jul 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Performance on the Cambridge Neuropsychological Test Automated Battery (CANTAB) - RVIP Reaction Time (time frame: Baseline, Day 5 and Day 10). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00606801.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Mar 2021.