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| ID | Type | Description | Link |
|---|---|---|---|
| R01DA015969-13 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute on Drug Abuse (NIDA) | NIH |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard Treatment As Usual (TAU) | No Intervention | Standard 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 Galantamine | Experimental | Standard 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. |
|
| TAU plus Computer Assisted Cognitive Behavioral Therapy (CBT) | Experimental | TAU 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. |
|
| TAU plus CBT plus galantamine | Experimental | Standard treatment, plus computer assisted cognitive behavioral therapy, plus galantamine. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Galantamine | Drug | Daily 8 mg galantamine capsule |
|
| Measure | Description | Time Frame |
|---|---|---|
| Cocaine Use | Reduction in cocaine use, operationalized as the frequency of cocaine use by month using timeline followback. | 12 weeks |
| 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 | 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kathleen M Carroll, Ph.D. | Yale University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kinsella Treatment Center (KTC) | Bridgeport | Connecticut | 06604 | United States | ||
| Regional Network of Programs |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29286595 | Derived | 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. |
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De-identified data will be available to other researchers upon request. Please contact Dr. Carroll
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| ID | Title | Description |
|---|---|---|
| FG000 | Galantamine and CBT | Drug: Galantamine Daily 8 mg galantamine capsule Other Names: Nivalin, Razadyne, Razadyne ER, Reminyl, Lycoremine Behavioral: Computer Assisted Cognitive Behavioral Therapy (CBT) 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. |
| FG001 | Galantamine Only | Drug: Galantamine Daily 8 mg galantamine capsule Other Names: Nivalin, Razadyne, Razadyne ER, Reminyl, Lycoremine |
| FG002 | Placebo and CBT | TAU 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. |
| FG003 | Placebo Only | Standard 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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|
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| ID | Title | Description |
|---|---|---|
| BG000 | Galantamine and CBT | Drug: Galantamine Daily 8 mg galantamine capsule Other Names: Nivalin, Razadyne, Razadyne ER, Reminyl, Lycoremine Behavioral: Computer Assisted Cognitive Behavioral Therapy (CBT) 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Cocaine Use | Reduction in cocaine use, operationalized as the frequency of cocaine use by month using timeline followback. | Presented are data for those measured at baseline and at 12 weeks. 2 individuals in the Galantamine arm were not measured at 12 weeks. | Posted | Mean | Standard Deviation | Days | 12 weeks |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Galantamine and CBT | Drug: Galantamine Daily 8 mg galantamine capsule Other Names: Nivalin, Razadyne, Razadyne ER, Reminyl, Lycoremine Behavioral: Computer Assisted Cognitive Behavioral Therapy (CBT) 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. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Inpatient Substance Use Treatment Hospitalization | Psychiatric disorders |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Fatigue | General disorders |
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Kathleen M. Carroll, Ph.D., Albert E Kent Professor of Psychiatry | Yale University School of Medicine | 203.937.3486 | 7403 | kathleen.carroll@yale.edu |
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| ID | Term |
|---|---|
| D019970 | Cocaine-Related Disorders |
| ID | Term |
|---|---|
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D005702 | Galantamine |
| ID | Term |
|---|---|
| D047151 | Amaryllidaceae Alkaloids |
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
| D001552 | Benzazepines |
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| Computer Assisted Cognitive Behavioral Therapy (CBT) | Behavioral | 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. |
|
| 12 weeks |
| Stratford |
| Connecticut |
| 06615 |
| United States |
| Withdrawal by Subject |
|
| BG001 | Galantamine | Drug: Galantamine Daily 8 mg galantamine capsule Other Names: Nivalin, Razadyne, Razadyne ER, Reminyl, Lycoremine |
| BG002 | Placebo and CBT | 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. |
| BG003 | Placebo Only | Standard 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. |
| BG004 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Number | participants |
|
| OG001 | Galantamine | Drug: Galantamine Daily 8 mg galantamine capsule Other Names: Nivalin, Razadyne, Razadyne ER, Reminyl, Lycoremine |
| OG002 | Placebo and CBT | 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. |
| OG003 | Placebo Only | Standard 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. |
|
|
| Primary | 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 | Three arm had one subject drop out before study medication was given- therefore the number analyzed are those that received first treatment. | Posted | Mean | Standard Deviation | percentage of negative urines | 12 weeks |
|
|
|
| Secondary | 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. | 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. | Posted | Mean | Standard Deviation | scores on a scale | 12 weeks |
|
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|
| 4 |
| 28 |
| 15 |
| 28 |
| EG001 | Galantamine | Drug: Galantamine Daily 8 mg galantamine capsule Other Names: Nivalin, Razadyne, Razadyne ER, Reminyl, Lycoremine | 6 | 27 | 10 | 27 |
| EG002 | Placebo and CBT | 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. | 6 | 38 | 16 | 38 |
| EG003 | Placebo Only | Standard 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. | 5 | 27 | 14 | 27 |
| Inpatient Psychiatric Hospitalization | Psychiatric disorders |
|
| Medical hospitalization | Gastrointestinal disorders |
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| Medical hospitalization | Surgical and medical procedures |
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| Medical Hospitalization | General disorders |
|
| agitation | General disorders |
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| headache | General disorders |
|
| Tremors | General disorders |
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| Dizziness | General disorders |
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| Nausea | Gastrointestinal disorders |
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| indigestion | Gastrointestinal disorders |
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| Blood in Stool | General disorders |
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| Abdominal Pain | General disorders |
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| Loss of Appetite | General disorders |
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| Diarrhea or Constipation | Gastrointestinal disorders |
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| Weight Loss | General disorders |
|
| Rash | Skin and subcutaneous tissue disorders |
|
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| D006574 |
| Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| Title | Measurements |
|---|---|
|