Trial Outcomes & Findings for Galantamine to Enhance Cognitive Behavioral Therapy for Cocaine Abuse (NCT NCT00809835)
NCT ID: NCT00809835
Last Updated: 2019-01-30
Results Overview
Reduction in cocaine use, operationalized as the frequency of cocaine use by month using timeline followback.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
120 participants
Primary outcome timeframe
12 weeks
Results posted on
2019-01-30
Participant Flow
Participant milestones
| Measure |
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.
|
Galantamine Only
Drug: Galantamine Daily 8 mg galantamine capsule
Other Names:
Nivalin, Razadyne, Razadyne ER, Reminyl, Lycoremine
|
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.
|
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.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
28
|
27
|
38
|
27
|
|
Overall Study
COMPLETED
|
20
|
20
|
27
|
25
|
|
Overall Study
NOT COMPLETED
|
8
|
7
|
11
|
2
|
Reasons for withdrawal
| Measure |
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.
|
Galantamine Only
Drug: Galantamine Daily 8 mg galantamine capsule
Other Names:
Nivalin, Razadyne, Razadyne ER, Reminyl, Lycoremine
|
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.
|
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.
|
|---|---|---|---|---|
|
Overall Study
Lost to Follow-up
|
7
|
6
|
10
|
2
|
|
Overall Study
Withdrawal by Subject
|
1
|
1
|
1
|
0
|
Baseline Characteristics
Galantamine to Enhance Cognitive Behavioral Therapy for Cocaine Abuse
Baseline characteristics by cohort
| Measure |
Galantamine and CBT
n=28 Participants
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.
|
Galantamine
n=27 Participants
Drug: Galantamine Daily 8 mg galantamine capsule
Other Names:
Nivalin, Razadyne, Razadyne ER, Reminyl, Lycoremine
|
Placebo and CBT
n=38 Participants
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.
|
Placebo Only
n=27 Participants
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.
|
Total
n=120 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
38.04 years
STANDARD_DEVIATION 8.72 • n=5 Participants
|
38.70 years
STANDARD_DEVIATION 10.79 • n=7 Participants
|
39.82 years
STANDARD_DEVIATION 8.99 • n=5 Participants
|
36.30 years
STANDARD_DEVIATION 9.41 • n=4 Participants
|
38.36 years
STANDARD_DEVIATION 9.43 • n=21 Participants
|
|
Sex: Female, Male
Female
|
12 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
16 Participants
n=4 Participants
|
62 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
16 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
11 Participants
n=4 Participants
|
58 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Caucasian
|
12 participants
n=5 Participants
|
15 participants
n=7 Participants
|
19 participants
n=5 Participants
|
16 participants
n=4 Participants
|
62 participants
n=21 Participants
|
|
Race/Ethnicity, Customized
African-American
|
7 participants
n=5 Participants
|
6 participants
n=7 Participants
|
9 participants
n=5 Participants
|
3 participants
n=4 Participants
|
25 participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Hispanic
|
9 participants
n=5 Participants
|
6 participants
n=7 Participants
|
9 participants
n=5 Participants
|
8 participants
n=4 Participants
|
32 participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Multiracial/Other
|
0 participants
n=5 Participants
|
0 participants
n=7 Participants
|
1 participants
n=5 Participants
|
0 participants
n=4 Participants
|
1 participants
n=21 Participants
|
PRIMARY outcome
Timeframe: 12 weeksPopulation: Presented are data for those measured at baseline and at 12 weeks. 2 individuals in the Galantamine arm were not measured at 12 weeks.
Reduction in cocaine use, operationalized as the frequency of cocaine use by month using timeline followback.
Outcome measures
| Measure |
Galantamine and CBT
n=28 Participants
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.
|
Galantamine
n=27 Participants
Drug: Galantamine Daily 8 mg galantamine capsule
Other Names:
Nivalin, Razadyne, Razadyne ER, Reminyl, Lycoremine
|
Placebo and CBT
n=38 Participants
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.
|
Placebo Only
n=27 Participants
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.
|
|---|---|---|---|---|
|
Cocaine Use
Baseline
|
18.82 Days
Standard Deviation 8.68
|
14.81 Days
Standard Deviation 9.05
|
15.68 Days
Standard Deviation 7.78
|
14.85 Days
Standard Deviation 8.47
|
|
Cocaine Use
12 Weeks
|
8.60 Days
Standard Deviation 6.95
|
6.32 Days
Standard Deviation 6.52
|
7.65 Days
Standard Deviation 7.41
|
10.25 Days
Standard Deviation 7.79
|
PRIMARY outcome
Timeframe: 12 weeksPopulation: Three arm had one subject drop out before study medication was given- therefore the number analyzed are those that received first treatment.
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
Outcome measures
| Measure |
Galantamine and CBT
n=27 Participants
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.
|
Galantamine
n=26 Participants
Drug: Galantamine Daily 8 mg galantamine capsule
Other Names:
Nivalin, Razadyne, Razadyne ER, Reminyl, Lycoremine
|
Placebo and CBT
n=37 Participants
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.
|
Placebo Only
n=27 Participants
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.
|
|---|---|---|---|---|
|
Cocaine Abstinence
|
22.45 percentage of negative urines
Standard Deviation 35.62
|
31.13 percentage of negative urines
Standard Deviation 34.16
|
20.49 percentage of negative urines
Standard Deviation 27.60
|
14.78 percentage of negative urines
Standard Deviation 19.11
|
SECONDARY outcome
Timeframe: 12 weeksPopulation: 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.
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.
Outcome measures
| Measure |
Galantamine and CBT
n=18 Participants
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.
|
Galantamine
n=22 Participants
Drug: Galantamine Daily 8 mg galantamine capsule
Other Names:
Nivalin, Razadyne, Razadyne ER, Reminyl, Lycoremine
|
Placebo and CBT
n=25 Participants
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.
|
Placebo Only
n=19 Participants
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.
|
|---|---|---|---|---|
|
Cognitive Function
|
-.12 scores on a scale
Standard Deviation .58
|
.11 scores on a scale
Standard Deviation .50
|
-.06 scores on a scale
Standard Deviation .71
|
.03 scores on a scale
Standard Deviation .49
|
Adverse Events
Galantamine and CBT
Serious events: 4 serious events
Other events: 15 other events
Deaths: 0 deaths
Galantamine
Serious events: 6 serious events
Other events: 10 other events
Deaths: 0 deaths
Placebo and CBT
Serious events: 6 serious events
Other events: 16 other events
Deaths: 0 deaths
Placebo Only
Serious events: 5 serious events
Other events: 14 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Galantamine and CBT
n=28 participants at risk
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.
|
Galantamine
n=27 participants at risk
Drug: Galantamine Daily 8 mg galantamine capsule
Other Names:
Nivalin, Razadyne, Razadyne ER, Reminyl, Lycoremine
|
Placebo and CBT
n=38 participants at risk
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.
|
Placebo Only
n=27 participants at risk
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.
|
|---|---|---|---|---|
|
Psychiatric disorders
Inpatient Substance Use Treatment Hospitalization
|
10.7%
3/28 • Number of events 5
|
7.4%
2/27 • Number of events 2
|
7.9%
3/38 • Number of events 5
|
18.5%
5/27 • Number of events 5
|
|
Psychiatric disorders
Inpatient Psychiatric Hospitalization
|
3.6%
1/28 • Number of events 1
|
7.4%
2/27 • Number of events 2
|
0.00%
0/38
|
0.00%
0/27
|
|
Gastrointestinal disorders
Medical hospitalization
|
0.00%
0/28
|
3.7%
1/27 • Number of events 1
|
0.00%
0/38
|
0.00%
0/27
|
|
Surgical and medical procedures
Medical hospitalization
|
0.00%
0/28
|
0.00%
0/27
|
2.6%
1/38 • Number of events 1
|
0.00%
0/27
|
|
General disorders
Medical Hospitalization
|
0.00%
0/28
|
3.7%
1/27 • Number of events 1
|
5.3%
2/38 • Number of events 2
|
0.00%
0/27
|
Other adverse events
| Measure |
Galantamine and CBT
n=28 participants at risk
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.
|
Galantamine
n=27 participants at risk
Drug: Galantamine Daily 8 mg galantamine capsule
Other Names:
Nivalin, Razadyne, Razadyne ER, Reminyl, Lycoremine
|
Placebo and CBT
n=38 participants at risk
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.
|
Placebo Only
n=27 participants at risk
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.
|
|---|---|---|---|---|
|
General disorders
Fatigue
|
7.1%
2/28 • Number of events 3
|
11.1%
3/27 • Number of events 5
|
21.1%
8/38 • Number of events 13
|
14.8%
4/27 • Number of events 7
|
|
General disorders
agitation
|
14.3%
4/28 • Number of events 5
|
0.00%
0/27
|
7.9%
3/38 • Number of events 3
|
3.7%
1/27 • Number of events 1
|
|
General disorders
headache
|
17.9%
5/28 • Number of events 6
|
22.2%
6/27 • Number of events 8
|
15.8%
6/38 • Number of events 9
|
11.1%
3/27 • Number of events 5
|
|
General disorders
Tremors
|
3.6%
1/28 • Number of events 1
|
0.00%
0/27
|
2.6%
1/38 • Number of events 1
|
0.00%
0/27
|
|
General disorders
Dizziness
|
10.7%
3/28 • Number of events 5
|
7.4%
2/27 • Number of events 3
|
5.3%
2/38 • Number of events 3
|
3.7%
1/27 • Number of events 1
|
|
Gastrointestinal disorders
Nausea
|
39.3%
11/28 • Number of events 17
|
7.4%
2/27 • Number of events 2
|
13.2%
5/38 • Number of events 14
|
22.2%
6/27 • Number of events 6
|
|
Gastrointestinal disorders
indigestion
|
7.1%
2/28 • Number of events 3
|
0.00%
0/27
|
7.9%
3/38 • Number of events 4
|
7.4%
2/27 • Number of events 2
|
|
General disorders
Blood in Stool
|
0.00%
0/28
|
0.00%
0/27
|
2.6%
1/38 • Number of events 1
|
0.00%
0/27
|
|
General disorders
Abdominal Pain
|
14.3%
4/28 • Number of events 5
|
3.7%
1/27 • Number of events 1
|
10.5%
4/38 • Number of events 5
|
3.7%
1/27 • Number of events 1
|
|
General disorders
Loss of Appetite
|
25.0%
7/28 • Number of events 10
|
7.4%
2/27 • Number of events 3
|
15.8%
6/38 • Number of events 8
|
11.1%
3/27 • Number of events 3
|
|
Gastrointestinal disorders
Diarrhea or Constipation
|
14.3%
4/28 • Number of events 7
|
0.00%
0/27
|
21.1%
8/38 • Number of events 13
|
11.1%
3/27 • Number of events 3
|
|
General disorders
Weight Loss
|
0.00%
0/28
|
0.00%
0/27
|
7.9%
3/38 • Number of events 3
|
3.7%
1/27 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/28
|
0.00%
0/27
|
2.6%
1/38 • Number of events 1
|
0.00%
0/27
|
Additional Information
Kathleen M. Carroll, Ph.D., Albert E Kent Professor of Psychiatry
Yale University School of Medicine
Phone: 203.937.3486
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place