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| ID | Type | Description | Link |
|---|---|---|---|
| R21DA025243 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute on Drug Abuse (NIDA) | NIH |
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For this project, the investigators are interested in exploring a new way to extend and maintain drug abstinence in people who are addicted to crack cocaine. This study will combine a medication called D-Cycloserine (DCS) and weekly cognitive behavioral therapy (CBT) to assess whether the combination will enhance people's ability to stay clean (drug free) for longer periods of time.
One of the greatest risks for drug relapse is drug craving. Oftentimes drug craving occurs when a person is confronted with stressors and reminders of past drug use behavior. DCS has been shown to enhance the learning of new information. By administering DCS prior to learning new techniques such as how to cope with drug craving and drug-use reminders, it is possible that patients can be more successful at living a drug free life for a longer period of time.
In addition to exploring this model behaviorally, the investigators will explore changes that may occur in the brain before and after the therapy/medication intervention. A technique called MRI (Magnetic Resonance Imaging) will be used to identify areas of the brain that are being activated during an attention task. Areas of neural activation will be assessed at study entry, end of therapy (4-week endpoint) and one month following completion of the treatment program.
Primary Hypothesis:
Enhancing glutamatergic neurotransmission with DCS facilitates CBT-related relapse prevention by potentiating the behavioral and neural representation of the diminished drug motivation associated with cocaine cues.
Specific Aims:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| DCS and Cognitive Behavioral Therapy | Experimental | Subjects will receive 250 mg of Seromycin or D-cycloserine (DCS) prior to computerized cognitive behavioral therapy. |
|
| Placebo and Cognitive Behavioral Therapy | Placebo Comparator | Subjects will receive a 250 mg identical looking placebo pill prior to computerized cognitive behavioral therapy. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Seromycin (D-cycloserine, DCS) | Drug | 250 mg DCS once weekly for 4 weeks prior to the initiation of a Computerized Cognitive Behavioral Therapy (CBT) session for drug relapse intervention. |
| Measure | Description | Time Frame |
|---|---|---|
| Drug Abstinence During Treatment and at Follow up Visits | Percentage of the overall number of drug abstinences of participants measured by urine drug testing | Participants provided urine samples for drug testing during treatment which occurred 3 times per week for 4 weeks, at the end of treatment, and at a 1 and 2 month follow up visit |
| Treatment Retention - Number of Visits During Treatment | Number of treatment visits attended prior to discontinuation of treatment | Treatment sessions included 3 visits per week for 4 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Clinton Kilts, PhD | University of Arkansas | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Psychiatric Research Institute (PRI) (Center for Addiction Research (CAR) and Brain Imaging Research Center (BIRC)) University of Arkansas for Medical Sciences | Little Rock | Arkansas | 72205 | United States |
Enrolled participants could have been excluded due to other drug dependencies, loss of consciousness > 10 min, neurologic disorder, severe hepatic insufficiency, significant cardiovascular disease, current psychiatric disorder, current medical illness, sensory impairment, positive pregnancy test.
Recruitment included outpatient and inpatient alcohol and drug abuse clinics, self-referrals, flyers in public places, and advertisements in newspapers. Recruitment started June 2010 and ended September 2011.
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| ID | Title | Description |
|---|---|---|
| FG000 | DCS and Cognitive Behavioral Therapy | Subjects will receive 250 mg of Seromycin or D-cycloserine (DCS) prior to computerized cognitive behavioral therapy. Seromycin (D-cycloserine, DCS) : 250 mg DCS once weekly for 4 weeks prior to the initiation of a Computerized Cognitive Behavioral Therapy (CBT) session for drug relapse intervention. |
| FG001 | Placebo and Cognitive Behavioral Therapy | Subjects will receive a 250 mg identical looking placebo pill prior to computerized cognitive behavioral therapy. Placebo : Placebo identical looking to the 250 mg DCS once weekly for 4 weeks prior to the initiation of a Computerized Cognitive Behavioral Therapy (CBT) session for drug relapse intervention. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
These numbers include participants that were eligible after the initial intake assessment and were assigned to a group.
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| ID | Title | Description |
|---|---|---|
| BG000 | DCS and Cognitive Behavioral Therapy | Subjects will receive 250 mg of Seromycin or D-cycloserine (DCS) prior to computerized cognitive behavioral therapy. Seromycin (D-cycloserine, DCS) : 250 mg DCS once weekly for 4 weeks prior to the initiation of a Computerized Cognitive Behavioral Therapy (CBT) session for drug relapse intervention. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| 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 | Drug Abstinence During Treatment and at Follow up Visits | Percentage of the overall number of drug abstinences of participants measured by urine drug testing | Total possible urine samples = 225 per arm. Not all participants stayed in treatment, therefore the total units analyzed will not match the total possible. | Posted | Number | percentage of drug abstinences | Participants provided urine samples for drug testing during treatment which occurred 3 times per week for 4 weeks, at the end of treatment, and at a 1 and 2 month follow up visit | Urine Samples | Participants |
|
1 year, 7 months
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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 | DCS and Cognitive Behavioral Therapy | Subjects will receive 250 mg of Seromycin or D-cycloserine (DCS) prior to computerized cognitive behavioral therapy. Seromycin (D-cycloserine, DCS) : 250 mg DCS once weekly for 4 weeks prior to the initiation of a Computerized Cognitive Behavioral Therapy (CBT) session for drug relapse intervention. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| cough | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment | Participant reported infrequent coughing. Physician determined it was not study related. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Clint Kilts, PhD | Brain Imaging Research Center | 526-8163 | CDKilts@uams.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 |
|---|---|
| D003523 | Cycloserine |
| ID | Term |
|---|---|
| D007555 | Isoxazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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|
| Placebo | Drug | Placebo identical looking to the 250 mg DCS once weekly for 4 weeks prior to the initiation of a Computerized Cognitive Behavioral Therapy (CBT) session for drug relapse intervention. |
|
| Computerized Cognitive Behavioral Therapy | Behavioral | All participants received Computerized Cognitive Behavioral Therapy sessions 3 times per week for 4 weeks as a drug relapse intervention. |
|
| participation in other tx study |
|
| BG001 |
| Placebo and Cognitive Behavioral Therapy |
Subjects will receive a 250 mg identical looking placebo pill prior to computerized cognitive behavioral therapy. Placebo : Placebo identical looking to the 250 mg DCS once weekly for 4 weeks prior to the initiation of a Computerized Cognitive Behavioral Therapy (CBT) session for drug relapse intervention. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG001 | Placebo and Cognitive Behavioral Therapy | Subjects will receive a 250 mg identical looking placebo pill prior to computerized cognitive behavioral therapy. Placebo : Placebo identical looking to the 250 mg DCS once weekly for 4 weeks prior to the initiation of a Computerized Cognitive Behavioral Therapy (CBT) session for drug relapse intervention. |
|
|
| Primary | Treatment Retention - Number of Visits During Treatment | Number of treatment visits attended prior to discontinuation of treatment | Total possible sessions attended = 180 per arm. Some participants did not complete all sessions, therefore the units analyzed will not match the total possible. | Posted | Mean | Standard Deviation | visits | Treatment sessions included 3 visits per week for 4 weeks | Sessions Attended | Participants |
|
|
|
| 0 |
| 29 |
| 3 |
| 29 |
| EG001 | Placebo and Cognitive Behavioral Therapy | Subjects will receive a 250 mg identical looking placebo pill prior to computerized cognitive behavioral therapy. Placebo : Placebo identical looking to the 250 mg DCS once weekly for 4 weeks prior to the initiation of a Computerized Cognitive Behavioral Therapy (CBT) session for drug relapse intervention. | 0 | 30 | 2 | 30 |
|
| headache | Nervous system disorders | Non-systematic Assessment | Participant reported mild headaches. Physician determined it was not study related. |
|
| nausea | General disorders | Non-systematic Assessment | Participant reported a nauseas feeling. Physician determined it was not study related. |
|
| sensation on skin | Skin and subcutaneous tissue disorders | Non-systematic Assessment | Participant reported a crawling sensation on skin. Physician determined it was not study related. |
|
| rash on skin | Skin and subcutaneous tissue disorders | Non-systematic Assessment | Participant reported a rash on skin. Physician determined it was not study related. |
|
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| D023303 |
| Oxazolidinones |
| D010080 | Oxazoles |
| D012694 | Serine |
| D021542 | Amino Acids, Neutral |
| D000596 | Amino Acids |
| D000602 | Amino Acids, Peptides, and Proteins |