Trial Outcomes & Findings for Anxiety in Recovering Opiate Dependence (NCT NCT00668265)
NCT ID: NCT00668265
Last Updated: 2013-02-18
Results Overview
Hamilton anxiety scale -- a well known quantitative measure for assessment of anxiety
TERMINATED
PHASE4
14 participants
16 weeks
2013-02-18
Participant Flow
The study was initiated in 2007 adn terminated in 2010 due to PI's departure. All recrutiement took place at Su Casa residential treatment facility in New York City. All recruitment was done by the PI.
The subjects were individuals with opiate addiction on agonist therapy. After recruitement subjects underwent methadone taper as inpatients. Most subjects left the study because they signed out of the Su Casa Program and did not complete their methadone taper.
Participant milestones
| Measure |
Quetiapine Arm
The participants were scheduled to receive Quetiapine, initially at a dose of 50 mg qHS for 2 days, followed by 100 mg qHS for 2 days, and then raised to a target dose of 150 mg qHS. Patients who do not tolerate that dose were titrated downwards in 50 mg increments until a tolerable dose is achieved. Medication dosage was further adjusted as necessary during the course of the study.
Concomitant Medications:
Concomitant psychotropic medications were not allowed. Concomitant medications for treatment of physical illnesses other than those indicated in the Exclusion Criteria were allowed
|
Placebo Arm
The subjects in the placebo arm received inactive pills in identical blister packs
|
|---|---|---|
|
Overall Study
STARTED
|
9
|
5
|
|
Overall Study
COMPLETED
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
9
|
5
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Anxiety in Recovering Opiate Dependence
Baseline characteristics by cohort
| Measure |
Quetiapine
n=9 Participants
Subjects on MMTP receiving quetiapine
|
Placebo
n=5 Participants
Subjects on methadone maintenance receiving placebo while inpatients in a methadone treatment facility Su Casa
|
Total
n=14 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
9 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
14 Participants
n=206 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age Continuous
|
43 years
STANDARD_DEVIATION 7.0 • n=99 Participants
|
45 years
STANDARD_DEVIATION 9 • n=107 Participants
|
43.8 years
STANDARD_DEVIATION 9 • n=206 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
11 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
9 participants
n=99 Participants
|
5 participants
n=107 Participants
|
14 participants
n=206 Participants
|
PRIMARY outcome
Timeframe: 16 weeksPopulation: Data was not analyzed: PI left the institution and the study was terminated
Hamilton anxiety scale -- a well known quantitative measure for assessment of anxiety
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 16 weeksPopulation: Data were not analyzed. PI left institution, and did not respond to attempts top contact him.
To compare the effect of Quetiapine vs. placebo on symptoms of negative mood in patients with GAD and comorbid opiate abuse in remission.
Outcome measures
Outcome data not reported
Adverse Events
Quetiapine
Placebo
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place