Trial · NCT00248612
Psychosocial and Medication Treatment for Anxiety in Alcoholism
NCT00248612, Phase 2, Phase 3, Completed, Boston Medical Center; results first posted 2017-08-17
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Psychosocial and Medication Treatment for Anxiety in Alcoholism. Trials, record NCT00248612. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00248612
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Psychosocial and Medication Treatment for Anxiety in Alcoholism
- NCT number
- NCT00248612
- Status
- Completed
- Phases
- Phase 2, Phase 3
- Enrollment
- 162 participants, actual
- Lead sponsor
- Boston Medical Center
- Conditions
- Alcohol-Related Disorders, Anxiety Disorders
- Interventions
- Venlafaxine, CBT, Progressive muscle relaxation therapy (PMR), Placebo medication
- First posted
- 2005-11-04
- Last updated
- 2018-01-24
- Results first posted
- 2017-08-17
- Limitations and caveats
Small size of treatment groups leading to diminished meaningful difference between comparison groups at follow-up; Failure of randomization leading to unequal number of subjects in each treatment group.
Source ClinicalTrials.gov
Registered outcomes9
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Clinical Global Impression Scale-I (CGI-I) | Session 1 (Baseline) , Session 8 (8 weeks of treatment), Session 11 (11 weeks of treatment) | Global improvement of alcohol dependence: Rate the total improvement in the participant's alcohol dependence symptoms whether or not, in your judgment, it is due entirely to treatment. Compared to his/her admission to the project, how much has s/he changed? (1-Not assessed, first rating, 2-Very much improved, 3-Much improved, 4-Minimally improved, 5-Unchanged, 6-Minimally worse, 7-Much worse, 8-Very much worse) |
| Primary | Clinical Global Impression Scale-S (CGI-S) | 1 (Baseline) , Session 8 (8 weeks of treatment), Session 11 (11 weeks of treatment) | Global severity of alcohol dependence: Considering your total clinical experience with the alcohol dependent population how severe are his/her alcohol dependence symptoms at this time? (1-Normal, no symptoms, 2-Borderline symptoms, 3-Mild symptoms, 4-Moderate symptoms, 5-Marked symptoms, 6-Severe symptoms, 7-Among the most extreme symptoms) |
| Primary | Craving Desire Scale (CDS) | 1 (Baseline) , Session 8 (8 weeks of treatment), Session 11 (11 weeks of treatment) | The Craving Desire Scale (CDS) is a 3-item scale ("1. I do want to drink now", "2. I crave a drink right now", 3. "I have a desire for a drink right now") used to identify the degree of current alcohol craving, with responses provided on a Likert scale of 1-7: with 1 meaning strongly disagree, and 7 meaning strongly agree to each of the 3 items. Total scores can range from 3 to 21 with higher scores indicating greater craving for alcohol. |
| Primary | Number of Participants Abstinent | Session 8 (8 weeks of treatment) | Abstaining from the consumption of intoxicating beverages. |
| Secondary | Treatment Completion | 12 months | The number and percent of participants that completed the treatment in each arm of the study. |
| Secondary | Medication Compliance Rates | 12 months | The medication compliance rate is the percentage of participants in each study arm who took their medication based on pill counts. |
| Secondary | DASS Stress Subscale Score | Session 1 (baseline), Session 11 (11 weeks of treatment) | DASS (Depression Anxiety Stress Scales) assesses depression, anxiety and stress responses. Each of the three DASS scales contains 14 items, divided into subscales of 2-5 items with similar content. The stress subscale was used which assesses difficulty relaxing, nervous arousal, and being easily upset/agitated, irritable/over-reactive and impatient. Subjects are asked to use 4-point severity/frequency scales to rate the extent to which they have experienced each state over the past week. Stress scores can range form 0-56 with 0-14=normal, 15-18=mild, 19-25=moderate, 26-33=severe. and 34+=extremely severe stress. |
| Secondary | HAM-A Scale | Session 1 (baseline), Session 8 (8 weeks of treatment) | The Hamilton Anxiety Rating Scale (HAM-A) is a psychological questionnaire used by clinicians to rate the severity of a patient's anxiety. The HAM-A probes 14 parameters each item is scored on a 5-point scale, ranging from 0=not present to 4=severe. total scores can range from 0 to 56.where \<17 indicates mild anxiety, 18-24 moderate anxiety and 25-30 severe anxiety. Higher scores reflect more anxiety. |
| Secondary | HAM-D Scale | Session 1 (baseline), Session 8 (8 weeks of treatment) | HAM-D (Hamilton Rating Scale for Depression) is a multiple item questionnaire used to provide an indication of depression, and as a guide to evaluate recovery. The scoring is based on 17 items. Eight of the items are scored on a 5-point scale, ranging from 0 = not present to 4 = severe. Nine items are scored on a 3 point scale from 0-2 where 0=none or absent and 2= severe. The total scores for the HAM-D can range from 0 to 50. The total scores are interpreted as: 0-7=normal, 8-13=mild, 14-18= moderate, 19-22= severe, and 23+=very severe depression. The higher the score the more severe the participant's depression. |
Source ClinicalTrials.gov
Outcomes9
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Clinical Global Impression Scale-I (CGI-I) | Session 1 (Baseline) , Session 8 (8 weeks of treatment), Session 11 (11 weeks of treatment) | units on a scale | MEAN | |
| PRIMARY | Clinical Global Impression Scale-S (CGI-S) | 1 (Baseline) , Session 8 (8 weeks of treatment), Session 11 (11 weeks of treatment) | units on a scale | MEAN | |
| PRIMARY | Craving Desire Scale (CDS) | 1 (Baseline) , Session 8 (8 weeks of treatment), Session 11 (11 weeks of treatment) | units on a scale | MEAN | |
| PRIMARY | Number of Participants Abstinent | Session 8 (8 weeks of treatment) | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Treatment Completion | 12 months | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Medication Compliance Rates | 12 months | percentage of participants | NUMBER | |
| SECONDARY | DASS Stress Subscale Score | Session 1 (baseline), Session 11 (11 weeks of treatment) | units on a scale | LEAST_SQUARES_MEAN | |
| SECONDARY | HAM-A Scale | Session 1 (baseline), Session 8 (8 weeks of treatment) | units on a scale | LEAST_SQUARES_MEAN | |
| SECONDARY | HAM-D Scale | Session 1 (baseline), Session 8 (8 weeks of treatment) | units on a scale | LEAST_SQUARES_MEAN |
Source ClinicalTrials.gov
Results by group72
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Clinical Global Impression Scale-I (CGI-I) | Venlafaxine & CBT | Session 1 CGI-I | 3.65 | Standard Deviation 1.34 | units on a scale |
| Clinical Global Impression Scale-I (CGI-I) | Placebo & CBT | Session 1 CGI-I | 3.81 | Standard Deviation 1.21 | units on a scale |
| Clinical Global Impression Scale-I (CGI-I) | Venlafaxine & PMR | Session 1 CGI-I | 3.86 | Standard Deviation 1.10 | units on a scale |
| Clinical Global Impression Scale-I (CGI-I) | Placebo & PMR | Session 1 CGI-I | 4.05 | Standard Deviation 0.65 | units on a scale |
| Clinical Global Impression Scale-I (CGI-I) | Venlafaxine & CBT | Session 8 CGI-I | 3.61 | Standard Deviation 1.38 | units on a scale |
| Clinical Global Impression Scale-I (CGI-I) | Placebo & CBT | Session 8 CGI-I | 3.13 | Standard Deviation 0.89 | units on a scale |
| Clinical Global Impression Scale-I (CGI-I) | Venlafaxine & PMR | Session 8 CGI-I | 3.50 | Standard Deviation 1.09 | units on a scale |
| Clinical Global Impression Scale-I (CGI-I) | Placebo & PMR | Session 8 CGI-I | 3.53 | Standard Deviation 1.19 | units on a scale |
| Clinical Global Impression Scale-I (CGI-I) | Venlafaxine & CBT | Session 11 CGI-I | 3.13 | Standard Deviation 1.30 | units on a scale |
| Clinical Global Impression Scale-I (CGI-I) | Placebo & CBT | Session 11 CGI-I | 2.61 | Standard Deviation 0.78 | units on a scale |
1 to 10 of 72Source ClinicalTrials.gov
See all 72 results by groupParticipant flow12
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Venlafaxine & CBT | 24 | |
| Overall Study | STARTED | Placebo & CBT | 21 | |
| Overall Study | STARTED | Venlafaxine & PMR | 14 | |
| Overall Study | STARTED | Placebo & PMR | 22 | |
| Overall Study | COMPLETED | Venlafaxine & CBT | 24 | |
| Overall Study | COMPLETED | Placebo & CBT | 21 | |
| Overall Study | COMPLETED | Venlafaxine & PMR | 14 | |
| Overall Study | COMPLETED | Placebo & PMR | 22 | |
| Overall Study | NOT COMPLETED | Venlafaxine & CBT | 0 | |
| Overall Study | NOT COMPLETED | Placebo & CBT | 0 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 participant flowAdverse events36
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| serious | suicidal ideation | Psychiatric disorders | Venlafaxine & CBT | 3 | 24 | 3 |
| serious | suicidal ideation | Psychiatric disorders | Placebo & CBT | 0 | 21 | 0 |
| serious | suicidal ideation | Psychiatric disorders | Venlafaxine & PMR | 1 | 14 | 1 |
| serious | suicidal ideation | Psychiatric disorders | Placebo & PMR | 0 | 22 | 0 |
| serious | nausea | Gastrointestinal disorders | Venlafaxine & CBT | 1 | 24 | 1 |
| serious | nausea | Gastrointestinal disorders | Placebo & CBT | 0 | 21 | 0 |
| serious | nausea | Gastrointestinal disorders | Venlafaxine & PMR | 0 | 14 | 0 |
| serious | nausea | Gastrointestinal disorders | Placebo & PMR | 0 | 22 | 0 |
| serious | insomnia | General disorders | Venlafaxine & CBT | 0 | 24 | 0 |
| serious | insomnia | General disorders | Placebo & CBT | 0 | 21 | 0 |
1 to 10 of 36Source ClinicalTrials.gov
See all 36 adverse eventsAdverse event totals12
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Venlafaxine & CBT | 0 | 24 |
| Total, all-cause mortality | Placebo & CBT | 0 | 21 |
| Total, all-cause mortality | Venlafaxine & PMR | 0 | 14 |
| Total, all-cause mortality | Placebo & PMR | 0 | 22 |
| Total, other adverse events | Venlafaxine & CBT | 0 | 24 |
| Total, other adverse events | Placebo & CBT | 0 | 21 |
| Total, other adverse events | Venlafaxine & PMR | 0 | 14 |
| Total, other adverse events | Placebo & PMR | 0 | 22 |
| Total, serious adverse events | Venlafaxine & CBT | 3 | 24 |
| Total, serious adverse events | Placebo & CBT | 1 | 21 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 adverse event totalsPapers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants1
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years |
|---|---|---|---|---|---|
| R01AA013727 | Cognitive-Behavioral Therapy & Venlafaxine Treatments For Anxiety In Alcoholism | CIRAULO, DOMENIC ANTHONY | BOSTON MEDICAL CENTER | NATIONAL INSTITUTE ON ALCOHOL ABUSE AND ALCOHOLISM | 2003 to 2007 |
Source NIH RePORTER
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT00248612
GET https://conductscience.org/api/trials/v1/NCT00248612/results?page=2