Trial Outcomes & Findings for Modulation of Pharmacologically Induced Alcohol Craving in Recently Detoxified Alcoholics (NCT NCT00605904)
NCT ID: NCT00605904
Last Updated: 2012-07-03
Results Overview
Alcohol craving was measured using the Penn Alcohol Craving Scale (PACS). It is a 5-item self-administered instrument that measures frequency, intensity, and duration of thoughts about drinking, along with ability to resist drinking. There is a single outcome score than ranges from 0 to 30, with 30 being the maximum amount of alcohol craving.
COMPLETED
PHASE2
37 participants
180 minutes after the start of the infusion
2012-07-03
Participant Flow
Participant milestones
| Measure |
Acamprosate
Subjects received 3 tablets of 333mg acamprosate three times daily
|
Placebo
Subjects received 3 tablets of placebo three times daily
|
|---|---|---|
|
Baseline Data Collection and Dosing
STARTED
|
13
|
21
|
|
Baseline Data Collection and Dosing
COMPLETED
|
13
|
16
|
|
Baseline Data Collection and Dosing
NOT COMPLETED
|
0
|
5
|
|
Infusion Sessions
STARTED
|
13
|
16
|
|
Infusion Sessions
Saline Infusion
|
13
|
14
|
|
Infusion Sessions
mCPP Infusion
|
12
|
13
|
|
Infusion Sessions
Yohimbine Infusion
|
12
|
15
|
|
Infusion Sessions
COMPLETED
|
12
|
13
|
|
Infusion Sessions
NOT COMPLETED
|
1
|
3
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Modulation of Pharmacologically Induced Alcohol Craving in Recently Detoxified Alcoholics
Baseline characteristics by cohort
| Measure |
Acamprosate
n=13 Participants
Subjects received 3 tablets of 333mg acamprosate three times daily
|
Placebo
n=21 Participants
Subjects received 3 tablets of placebo three times daily
|
Total
n=34 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
13 Participants
n=5 Participants
|
21 Participants
n=7 Participants
|
34 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
12 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
30 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
13 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
33 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
3 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
9 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 180 minutes after the start of the infusionPopulation: The analyses included only those subjects who completed all three types of infusions (saline, meta-Chlorophenylpiperazine, and yohimbine)
Alcohol craving was measured using the Penn Alcohol Craving Scale (PACS). It is a 5-item self-administered instrument that measures frequency, intensity, and duration of thoughts about drinking, along with ability to resist drinking. There is a single outcome score than ranges from 0 to 30, with 30 being the maximum amount of alcohol craving.
Outcome measures
| Measure |
Acamprosate
n=12 Participants
Subjects received 3 tablets of 333mg acamprosate three times daily
|
Placebo
n=13 Participants
Subjects received 3 tablets of placebo three times daily
|
|---|---|---|
|
Alcohol Craving Rating in Response to Saline Infusion
|
1.704 Units on a scale
Standard Error 0.715
|
1.766 Units on a scale
Standard Error 0.627
|
PRIMARY outcome
Timeframe: 180 minutes after the start of the infusionPopulation: The analyses included only those subjects who completed all three types of infusions (saline, meta-Chlorophenylpiperazine, and yohimbine)
Alcohol craving was measured using the Penn Alcohol Craving Scale (PACS). It is a 5-item self-administered instrument that measures frequency, intensity, and duration of thoughts about drinking, along with ability to resist drinking. There is a single outcome score than ranges from 0 to 30, with 30 being the maximum amount of alcohol craving.
Outcome measures
| Measure |
Acamprosate
n=12 Participants
Subjects received 3 tablets of 333mg acamprosate three times daily
|
Placebo
n=13 Participants
Subjects received 3 tablets of placebo three times daily
|
|---|---|---|
|
Alcohol Craving Rating in Response to Meta-Chlorophenylpiperazine
|
3.460 Units on a scale
Standard Error 1.352
|
5.416 Units on a scale
Standard Error 1.185
|
PRIMARY outcome
Timeframe: 180 minutes after the start of the infusionPopulation: The analyses included only those subjects who completed all three types of infusions (saline, meta-Chlorophenylpiperazine, and yohimbine)
Alcohol craving was measured using the Penn Alcohol Craving Scale (PACS). It is a 5-item self-administered instrument that measures frequency, intensity, and duration of thoughts about drinking, along with ability to resist drinking. There is a single outcome score than ranges from 0 to 30, with 30 being the maximum amount of alcohol craving.
Outcome measures
| Measure |
Acamprosate
n=12 Participants
Subjects received 3 tablets of 333mg acamprosate three times daily
|
Placebo
n=13 Participants
Subjects received 3 tablets of placebo three times daily
|
|---|---|---|
|
Alcohol Craving Rating in Response to Yohimbine Infusion
|
3.613 Units on a scale
Standard Error 1.140
|
3.606 Units on a scale
Standard Error 1.000
|
Adverse Events
Acamprosate
Placebo
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Acamprosate
n=12 participants at risk
Subjects received 3 tablets of 333mg acamprosate three times daily
|
Placebo
n=13 participants at risk
Subjects received 3 tablets of placebo three times daily
|
|---|---|---|
|
General disorders
Abnormal Dreaming
|
41.7%
5/12
|
38.5%
5/13
|
|
General disorders
Abundance of Energy
|
50.0%
6/12
|
53.8%
7/13
|
|
General disorders
Aggressiveness
|
0.00%
0/12
|
7.7%
1/13
|
|
Psychiatric disorders
Agitation
|
16.7%
2/12
|
7.7%
1/13
|
|
Psychiatric disorders
Anxiety
|
16.7%
2/12
|
23.1%
3/13
|
|
Respiratory, thoracic and mediastinal disorders
Coughing Spells
|
16.7%
2/12
|
15.4%
2/13
|
|
Reproductive system and breast disorders
Decreased Interest in Sex
|
8.3%
1/12
|
46.2%
6/13
|
|
Gastrointestinal disorders
Diarrhea
|
25.0%
3/12
|
15.4%
2/13
|
|
General disorders
Dry Mouth
|
8.3%
1/12
|
23.1%
3/13
|
|
General disorders
Euphoria
|
8.3%
1/12
|
15.4%
2/13
|
|
Psychiatric disorders
Feeling Down
|
8.3%
1/12
|
15.4%
2/13
|
|
General disorders
Headaches
|
25.0%
3/12
|
7.7%
1/13
|
|
Cardiac disorders
Heart Racing
|
8.3%
1/12
|
7.7%
1/13
|
|
General disorders
Impaired Concentration
|
16.7%
2/12
|
15.4%
2/13
|
|
Psychiatric disorders
Irritability
|
16.7%
2/12
|
7.7%
1/13
|
|
Metabolism and nutrition disorders
Lack of Appetite
|
8.3%
1/12
|
0.00%
0/13
|
|
General disorders
Lack of Energy
|
25.0%
3/12
|
38.5%
5/13
|
|
Psychiatric disorders
Mood Swings
|
8.3%
1/12
|
15.4%
2/13
|
|
Musculoskeletal and connective tissue disorders
Muscle Spasms
|
16.7%
2/12
|
7.7%
1/13
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/12
|
7.7%
1/13
|
|
General disorders
Nervousness
|
0.00%
0/12
|
15.4%
2/13
|
|
Reproductive system and breast disorders
Painful Erections
|
0.00%
0/12
|
7.7%
1/13
|
|
Psychiatric disorders
Paranoid
|
0.00%
0/12
|
7.7%
1/13
|
|
Skin and subcutaneous tissue disorders
Rash
|
16.7%
2/12
|
23.1%
3/13
|
|
General disorders
Restlessness
|
25.0%
3/12
|
15.4%
2/13
|
|
Skin and subcutaneous tissue disorders
Sensation of Prickling
|
8.3%
1/12
|
7.7%
1/13
|
|
General disorders
Shakiness
|
8.3%
1/12
|
15.4%
2/13
|
|
Skin and subcutaneous tissue disorders
Skin Flushing
|
0.00%
0/12
|
7.7%
1/13
|
|
General disorders
Sleepiness
|
50.0%
6/12
|
53.8%
7/13
|
|
General disorders
Sleeplessness
|
50.0%
6/12
|
46.2%
6/13
|
|
Gastrointestinal disorders
Stomach Ache
|
16.7%
2/12
|
15.4%
2/13
|
|
Respiratory, thoracic and mediastinal disorders
Tightening of Airways
|
0.00%
0/12
|
7.7%
1/13
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/12
|
7.7%
1/13
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place