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Cocaine DependencePhase 2NCT00809835

Galantamine to Enhance Cognitive Behavioral Therapy for Cocaine Abuse

A Phase 2 study testing Galantamine and Computer Assisted Cognitive Behavioral Therapy (CBT) in people with Cocaine Dependence, run by Yale University at 2 sites in United States.

Completed

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

Official record
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Trial summary

We are testing to see if Galantamine, a learning enhancing medication, will help methadone maintained cocaine abusers with their learning and memory specific to CBT using an innovative CBT computer program. Read more about this study

Who is it for?
Ages 18 to 50 years
Conditions the study is for
Cocaine Dependence
What is being tested?
Galantamine and Computer Assisted Cognitive Behavioral Therapy (CBT)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
120 participants
Where
2 sitesUnited States
Study dates
Dec 2007to Jan 2015
Phase
Phase 2
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 18 to 50 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • Males and females between ages of 18 and 50
  • Enrolled in RNP methadone program and stable on methadone for at least 3 weeks
  • Current cocaine abuse or dependence according to DSM-IV criteria
  • No current medical problems and normal ECG
  • If female, not currently pregnant or breast feeding and using reliable birth control
  • Fluent in English and have at least a 6th grade reading level
  • Can commit to 12 weeks of treatment and are willing to be randomized

Who cannot join

  • Current major psychiatric illness including mood, psychotic or anxiety disorder
  • History of major medical illnesses including asthma, chronic obstructive lung disease, gastrointestinal ulcer, hepatic or renal impairment, cardiac rhythm disturbances
  • Use of medications including beta blockers and NASAIDs
  • Known allergy to Galantamine

Trial locations and contacts

2 sites in 1 country.

United States2 sites

  • Kinsella Treatment Center (KTC)

    Bridgeport, Connecticut, 06604

  • Regional Network of Programs

    Stratford, Connecticut, 06615

Other trials in United States

About this study

Official title: Galantamine to Enhance Cognitive Behavioral Therapy for Cocaine Abuse With Methadone Maintained Individuals

We are testing to see if Galantamine, a learning enhancing medication, will help methadone maintained cocaine abusers with their learning and memory specific to CBT using an innovative CBT computer program.

Read the detailed description

We are proposing a randomized double blind clinical trial of galantamine and our innovative computer-assisted version of CBT, alone and in combination, to improve treatment outcome and cognitive functioning among cocaine users. The proposed study will be the first to evaluate a cognitive enhancing medication as a means of enhancing the effects of an extremely promising empirically validated behavioral therapy for addiction, and hence bridge cognitive neuroscience and behavioral therapies development.

The aim is to conduct a 12 week randomized placebo controlled trial, using a 2x2 factorial model, that will evaluate the efficacy of adding computer assisted training in CBT ("CBT4CBT") and galantamine to standard treatment for 160 cocaine abusing or dependent methadone-maintained individuals. Participants will be randomized to (1) standard treatment (TAU) plus placebo, (2) TAU plus galantamine, (3) TAU plus CBT4CBT plus placebo, or (4) TAU plus CBT4CBT plus galantamine.

Being tested
Galantamine, Computer Assisted Cognitive Behavioral Therapy (CBT)
Keywords
Cocaine, Methadone, CBT
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, Lycoremine

    Daily 8 mg galantamine capsule

  • Computer Assisted Cognitive Behavioral Therapy (CBT)Behavioural

    CBT a psychotherapeutic approach that addresses dysfunctional emotions, maladaptive behaviors and cognitive processes and contents through a number of goal-oriented, explicit systematic procedures. The name refers to behavior therapy, cognitive therapy, and to therapy based upon a combination of basic behavioral and cognitive principles and research.

Study groups in NCT00809835
Study groupRoleWhat they receive
Standard Treatment As Usual (TAU)No interventionStandard Treatment plus placebo for cocaine abusing or dependent methadone-maintained individuals. This consists of daily methadone visits plus one individual and one group session per week, and patients may participate in additional treatments such as HIV education and treatment. The counseling program's theoretical orientation is described as client-centered.
TAU Plus GalantamineExperimentalStandard treatment plus Galantamine. In this study, we will use 8 mg galantamine extended release (ER). Galantamine ER is used once daily. The recommended initial dose is 8 mg/day and the maintenance dose is 16-24 mg/day.
Receives: Drug: Galantamine
TAU plus Computer Assisted Cognitive Behavioral Therapy (CBT)ExperimentalTAU plus computer assisted CBT plus placebo. All participants assigned to this condition will also be offered up to 60 minutes per week to work with the CBT for CBT program, onsite at the clinic, in a private space and using a computer provided by the research project. Patients will have the choice of how they choose to use the computer, that is, in two 30-minute sessions or one one-hour session.
Receives: Behavioral: Computer Assisted Cognitive Behavioral Therapy (CBT)
TAU plus CBT plus galantamineExperimentalStandard treatment, plus computer assisted cognitive behavioral therapy, plus galantamine.
Receives: Drug: Galantamine; Behavioral: Computer Assisted Cognitive Behavioral Therapy (CBT)

What is being measured

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

  1. Cocaine Use

    Reduction in cocaine use, operationalized as the frequency of cocaine use by month using timeline followback.

    Measured: 12 weeks

  2. Cocaine Abstinence

    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

    Measured: 12 weeks

Secondary outcomes (1)

  1. Cognitive Function

    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.

    Measured: 12 weeks

Timeline

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

  1. First posted17 Dec 2008 (estimated)
  2. Study startDec 2007
  3. Primary completionJan 2015
  4. Study completionJan 2015

Resources

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 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Factorial
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
120 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00809835
Sponsor's protocol ID
0708002943
Other IDs
R01DA015969-13
Status last verified
Jan 2019
First submitted
16 Dec 2008
Last updated
30 Jan 2019
Data monitoring committee
Yes
Individual data sharing
Yes: De-identified data will be available to other researchers upon request. Please contact Dr. Carroll

Publications

  • Carroll KM, Nich C, DeVito EE, Shi JM, Sofuoglu M. Galantamine and Computerized Cognitive Behavioral Therapy for Cocaine Dependence: A Randomized Clinical Trial. J Clin Psychiatry. 2018 Jan/Feb;79(1):17m11669. doi: 10.4088/JCP.17m11669.

    PubMed 29286595

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Galantamine and Computer Assisted Cognitive Behavioral Therapy (CBT) in people with Cocaine Dependence, run by Yale University at 2 sites 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 30 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 12 Jun 2017). 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?

Cocaine Use (time frame: 12 weeks). The study lists 2 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 NCT00809835, which also lists 1 linked publication.

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 30 Jan 2019.

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