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| ID | Type | Description | Link |
|---|---|---|---|
| R01DA017904 | U.S. NIH Grant/Contract | View source |
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The investigators failed to recruit participants as originally projected.
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| Name | Class |
|---|---|
| National Institute on Drug Abuse (NIDA) | NIH |
| Massachusetts General Hospital | OTHER |
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This study examines whether isolated doses of d-cycloserine enhance the efficacy of an exposure-based cognitive-behavioral treatment for chronic and treatment refractory substance dependence.
This is a placebo-controlled trial of the efficacy of 50mg d-cycloserine or matching pill placebo for enhancing the efficacy of CBT.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| DCS-augmented CBT-IC | Experimental | D-cycloserine-augmented CBT-IC |
|
| Placebo-augmented CBT-IC | Placebo Comparator | Placebo-augmented CBT-IC |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| D-cycloserine | Drug | Single dosage of D-cycloserine is given prior to each of 6 sessions of CBT-IC treatment (sessions 5-10) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Positive Toxicology Swabs for Illicit Substances | The primary outcome assessment for this study was the percentage of oral toxicology swabs that were positive of illicit substances. Participants completed these swabs at each assessment point, as well as at each study therapy session. Toxicology swabs were supervised by study staff and used oral specimen collection to screen for opiates, methadone, cocaine, benzodiazepines, amphetamines, THC, and barbiturates. | Weekly assessments with summation over three time periods: baseline, treatment (week 12), and follow-up (week 18) |
| Measure | Description | Time Frame |
|---|---|---|
| Addiction Severity Index (ASI) Drug Use Composite Score | For the drug use composite scores, each of 13 questions about drug use is divided by its maximum answer value and by the total number of questions in the composite. These individual items are then summed, so that possible total scores range from 0 to 1, with higher scores reflecting greater drug use problem severity. | Baseline, Mid Treatment (week 6), End of Treatment (week 12), Follow-up 1 (week 15), Follow-up 2 (week 18) |
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Inclusion criteria:
The primary selection criteria include women and men between the ages of 18 and 65 who:
Meet DSM-IV criteria for opiate dependence,
Maintain a stable dose of methadone for two weeks prior to recruitment and:
Meet study criteria for chronic stress:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Michael W. Otto, Ph.D. | Boston University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Habit OPCO | Boston | Massachusetts | 02118 | United States |
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15 people consented to this study but 4 did not meet entry criteria and 1 was loss to follow-up before completing baseline evaluations. 10 participants were randomized and 5 dropped out before taking study drug.
This pilot study was terminated due to inadequate recruitment. The primary reason was unwillingness to take a study drug (a parent study that did not require randomized drug was likely a factor in this decision).
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| ID | Title | Description |
|---|---|---|
| FG000 | All Randomized Participants | The blind was never broken for the study drug, therefore, results can only be presented aggregated for all randomized participants. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
10 participants were randomized out of the initial15 who consented to the study
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| ID | Title | Description |
|---|---|---|
| BG000 | Overall Study Characteristics | All participants who consented to be in the study |
| 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 | Percentage of Positive Toxicology Swabs for Illicit Substances | The primary outcome assessment for this study was the percentage of oral toxicology swabs that were positive of illicit substances. Participants completed these swabs at each assessment point, as well as at each study therapy session. Toxicology swabs were supervised by study staff and used oral specimen collection to screen for opiates, methadone, cocaine, benzodiazepines, amphetamines, THC, and barbiturates. | Toxicology swabs were obtained on all 10 randomized participants irrespective of taking study drug. At baseline all 10 had toxicology swabs, at treatment (week 12) 7 had toxicology swabs and at follow-up (week 18) 7 had toxicology swabs. | Posted | Mean | Standard Deviation | percentage of positive toxicology swabs | Weekly assessments with summation over three time periods: baseline, treatment (week 12), and follow-up (week 18) |
|
One year
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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 | All Randomized Participants | 10 participants were randomized and 5 dropped out before taking study drug. The blind was never broken for the study drug, Therefore, results can only be presented aggregated for all randomized participants. |
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Study was terminated due to low enrollment/adherence with the study drug. 10 participants were randomized, 5 dropped out before taking study drug. The blind was never broken so results can only be presented aggregated for all randomized participants.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Michael W. Otto, Ph.D. | BostonUCRC | (617)353-9610 | mwotto@bu.edu |
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| ID | Term |
|---|---|
| D019966 | Substance-Related Disorders |
| D009293 | Opioid-Related Disorders |
| ID | Term |
|---|---|
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
| D000079524 | Narcotic-Related 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 | Single dosage of placebo is given prior to each of 6 sessions of CBT-IC treatment (sessions 5-10) |
|
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
10 participants were randomized and 5 dropped out before taking study drug. The blind was never broken for the study drug, Therefore, results can only be presented aggregated for all randomized participants. |
|
|
| Secondary | Addiction Severity Index (ASI) Drug Use Composite Score | For the drug use composite scores, each of 13 questions about drug use is divided by its maximum answer value and by the total number of questions in the composite. These individual items are then summed, so that possible total scores range from 0 to 1, with higher scores reflecting greater drug use problem severity. | All randomized participants were asked to complete the ASI irrespective of taking study drug. At least one ASI was completed by 8 of the 10 randomized participants. At baseline 8 completed the ASI and the number of participants at each subsequent time point varied. | Posted | Mean | Standard Deviation | units on a scale | Baseline, Mid Treatment (week 6), End of Treatment (week 12), Follow-up 1 (week 15), Follow-up 2 (week 18) |
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|
| 0 |
| 10 |
| 0 |
| 10 |
| 0 |
| 10 |
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| D023303 |
| Oxazolidinones |
| D010080 | Oxazoles |
| D012694 | Serine |
| D021542 | Amino Acids, Neutral |
| D000596 | Amino Acids |
| D000602 | Amino Acids, Peptides, and Proteins |
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| Endpoint of Treatment (week 12) |
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| Follow-Up 1 (week 15) |
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| Follow-Up 2 (week 18) |
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