Trial Outcomes & Findings for A Sequenced Behavioral and Medication Intervention for Cocaine Dependence (NCT NCT01986075)
NCT ID: NCT01986075
Last Updated: 2022-01-25
Results Overview
The primary outcome measure will be a binary indicator (yes or no) of at least 3 consecutive weeks of urine toxicology confirmed self-reported abstinence during the last three weeks of the trial.
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
145 participants
Primary outcome timeframe
weeks 12-14 of trial
Results posted on
2022-01-25
Participant Flow
Of the 145 participants enrolled, 21 participants were designated as treatment responders during the first month of the psychosocial intervention and were not randomized. An additional 38 individuals were lost to follow-up or not eligible to be randomized prior to completing the first month of the intervention. Eighty-six participants continued to use cocaine through the first month of treatment and were randomized to receive either MAS-XR or Placebo at the beginning of treatment week 5.
Participant milestones
| Measure |
Computer-assisted CBT Plus Mixed-Amphetamine Salts- Extended Release (MAS-ER)
Patients who are randomized to the computer-assisted behavior therapy plus mixed amphetamine salts (extended release) arm will have their dose titrated to 80 mg or the maximum tolerated extended release mixed amphetamine salts daily. Participants will be asked to take the medication once per day in the morning or early afternoon and will be maintained on this schedule through week 14 of the trial. Computer-assisted behavior therapy based on the Community Reinforcement Approach (CRA) to treating cocaine dependence. CRA is skills based treatment program that incorporates coping skills development and contingency management. Participants will attend the clinic 3x per week and receive counseling 2x per week.
Computer-assisted behavior therapy: TES is a computer-assisted therapy program delivered via effective informational and multimedia technologies, includes 32 core interactive, multimedia modules, beginning with basic cognitive behavioral relapse prevention skills (e.g. drug refusal skills) and moving on to improving psychosocial functioning, (e.g. employment status, social relations) and HIV risk reduction.
Mixed amphetamine salts: 80 mg/day of Mixed-Amphetamine Salts- Extended Release (MAS-ER) and computer -assisted CBT
|
Computer-assisted CBT Plus Placebo
Patients who are randomized to the Computer-assisted CBT plus placebo arm will have their medication dose titrated in a fix-flexible dose schedule matching the active medication arm. Participants will be asked to take the medication once per day in the morning or early afternoon and will be maintained on this schedule through week 14 of the trial. Computer-assisted behavior therapy based on the Community Reinforcement Approach (CRA) to treating cocaine dependence. CRA is skills based treatment program that incorporates coping skills development and contingency management. Participants will attend the clinic 3x per week and receive counseling 2x per week.
Computer-assisted behavior therapy: TES is a computer-assisted therapy program delivered via effective informational and multimedia technologies, includes 32 core interactive, multimedia modules, beginning with basic cognitive behavioral relapse prevention skills (e.g. drug refusal skills) and moving on to improving psychosocial functioning, (e.g. employment status, social relations) and HIV risk reduction.
Placebo: Will receive computer -assisted CBT and placebo (instead of active Adderall-XR)
|
Computer- Assisted CBT With Contingency Management
All participants received computer-assisted CBT with contingency management (CRA + CM) during the first 4 week period of the trial.
|
|---|---|---|---|
|
Initial CBT + CM (Pre-randomization)
STARTED
|
0
|
0
|
145
|
|
Initial CBT + CM (Pre-randomization)
COMPLETED
|
0
|
0
|
86
|
|
Initial CBT + CM (Pre-randomization)
NOT COMPLETED
|
0
|
0
|
59
|
|
Randomized Intervention
STARTED
|
45
|
41
|
0
|
|
Randomized Intervention
COMPLETED
|
30
|
27
|
0
|
|
Randomized Intervention
NOT COMPLETED
|
15
|
14
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Sequenced Behavioral and Medication Intervention for Cocaine Dependence
Baseline characteristics by cohort
| Measure |
Computer-assisted CBT Plus Mixed-Amphetamine Salts- Extended Release (MAS-ER)
n=45 Participants
Patients who are randomized to the computer-assisted behavior therapy plus mixed amphetamine salts (extended release) arm will have their dose titrated to 80 mg or the maximum tolerated extended release mixed amphetamine salts daily. Participants will be asked to take the medication once per day in the morning or early afternoon and will be maintained on this schedule through week 14 of the trial. Computer-assisted behavior therapy based on the Community Reinforcement Approach (CRA) to treating cocaine dependence. CRA is skills based treatment program that incorporates coping skills development and contingency management. Participants will attend the clinic 3x per week and receive counseling 2x per week.
Computer-assisted behavior therapy: TES is a computer-assisted therapy program delivered via effective informational and multimedia technologies, includes 32 core interactive, multimedia modules, beginning with basic cognitive behavioral relapse prevention skills (e.g. drug refusal skills) and moving on to improving psychosocial functioning, (e.g. employment status, social relations) and HIV risk reduction.
Mixed amphetamine salts: 80 mg/day of Mixed-Amphetamine Salts- Extended Release (MAS-ER) and computer -assisted CBT
|
Computer-assisted CBT Plus Placebo
n=41 Participants
Patients who are randomized to the Computer-assisted CBT plus placebo arm will have their medication dose titrated in a fix-flexible dose schedule matching the active medication arm. Participants will be asked to take the medication once per day in the morning or early afternoon and will be maintained on this schedule through week 14 of the trial. Computer-assisted behavior therapy based on the Community Reinforcement Approach (CRA) to treating cocaine dependence. CRA is skills based treatment program that incorporates coping skills development and contingency management. Participants will attend the clinic 3x per week and receive counseling 2x per week.
Computer-assisted behavior therapy: TES is a computer-assisted therapy program delivered via effective informational and multimedia technologies, includes 32 core interactive, multimedia modules, beginning with basic cognitive behavioral relapse prevention skills (e.g. drug refusal skills) and moving on to improving psychosocial functioning, (e.g. employment status, social relations) and HIV risk reduction.
Placebo: Will receive computer -assisted CBT and placebo (instead of active Adderall-XR)
|
Non-randomized Individuals
n=59 Participants
Patients who were enrolled in the initial 4 week period and received CBT + CM but were not eligible to be randomized and did not enter the second randomized period of the trial.
|
Total
n=145 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
44.7 years
STANDARD_DEVIATION 10.1 • n=5 Participants
|
44.6 years
STANDARD_DEVIATION 9.8 • n=7 Participants
|
42.9 years
STANDARD_DEVIATION 10.1 • n=5 Participants
|
44.0 years
STANDARD_DEVIATION 10.0 • n=4 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
23 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
38 Participants
n=5 Participants
|
33 Participants
n=7 Participants
|
51 Participants
n=5 Participants
|
122 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
11 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
35 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
34 Participants
n=5 Participants
|
32 Participants
n=7 Participants
|
44 Participants
n=5 Participants
|
110 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
5 Participants
n=4 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
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
20 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
23 Participants
n=5 Participants
|
60 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
19 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
22 Participants
n=5 Participants
|
61 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
3 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
13 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
45 participants
n=5 Participants
|
41 participants
n=7 Participants
|
59 participants
n=5 Participants
|
145 participants
n=4 Participants
|
|
Number of days of cocaine use during prior 28 days
|
11.4 days
STANDARD_DEVIATION 6.1 • n=5 Participants
|
13.9 days
STANDARD_DEVIATION 7.2 • n=7 Participants
|
12.2 days
STANDARD_DEVIATION 7.4 • n=5 Participants
|
12.6 days
STANDARD_DEVIATION 6.7 • n=4 Participants
|
PRIMARY outcome
Timeframe: weeks 12-14 of trialThe primary outcome measure will be a binary indicator (yes or no) of at least 3 consecutive weeks of urine toxicology confirmed self-reported abstinence during the last three weeks of the trial.
Outcome measures
| Measure |
Computer-assisted CBT Plus Mixed-Amphetamine Salts- Extended Release (MAS-ER)
n=45 Participants
Patients who are randomized to the computer-assisted behavior therapy plus mixed amphetamine salts (extended release) arm will have their dose titrated to 80 mg or the maximum tolerated extended release mixed amphetamine salts daily. Participants will be asked to take the medication once per day in the morning or early afternoon and will be maintained on this schedule through week 14 of the trial. Computer-assisted behavior therapy based on the Community Reinforcement Approach (CRA) to treating cocaine dependence. CRA is skills based treatment program that incorporates coping skills development and contingency management. Participants will attend the clinic 3x per week and receive counseling 2x per week.
Computer-assisted behavior therapy: TES is a computer-assisted therapy program delivered via effective informational and multimedia technologies, includes 32 core interactive, multimedia modules, beginning with basic cognitive behavioral relapse prevention skills (e.g. drug refusal skills) and moving on to improving psychosocial functioning, (e.g. employment status, social relations) and HIV risk reduction.
Mixed amphetamine salts: 80 mg/day of Mixed-Amphetamine Salts- Extended Release (MAS-ER) and computer -assisted CBT
|
Computer-assisted CBT Plus Placebo
n=41 Participants
Patients who are randomized to the Computer-assisted CBT plus placebo arm will have their medication dose titrated in a fix-flexible dose schedule matching the active medication arm. Participants will be asked to take the medication once per day in the morning or early afternoon and will be maintained on this schedule through week 14 of the trial. Computer-assisted behavior therapy based on the Community Reinforcement Approach (CRA) to treating cocaine dependence. CRA is skills based treatment program that incorporates coping skills development and contingency management. Participants will attend the clinic 3x per week and receive counseling 2x per week.
Computer-assisted behavior therapy: TES is a computer-assisted therapy program delivered via effective informational and multimedia technologies, includes 32 core interactive, multimedia modules, beginning with basic cognitive behavioral relapse prevention skills (e.g. drug refusal skills) and moving on to improving psychosocial functioning, (e.g. employment status, social relations) and HIV risk reduction.
Placebo: Will receive computer -assisted CBT and placebo (instead of active Adderall-XR)
|
|---|---|---|
|
Those Achieving Three Consecutive Weeks of Cocaine Abstinence at the End of the Trial.
|
7 Participants
|
5 Participants
|
Adverse Events
Computer-assisted CBT Plus Mixed-Amphetamine Salts- Extended Release (MAS-ER)
Serious events: 1 serious events
Other events: 26 other events
Deaths: 0 deaths
Computer-assisted CBT Plus Placebo
Serious events: 1 serious events
Other events: 11 other events
Deaths: 0 deaths
Non-randomized CBT Plus CM
Serious events: 4 serious events
Other events: 2 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Computer-assisted CBT Plus Mixed-Amphetamine Salts- Extended Release (MAS-ER)
n=45 participants at risk
Patients who are randomized to the computer-assisted behavior therapy plus mixed amphetamine salts (extended release) arm will have their dose titrated to 80 mg or the maximum tolerated extended release mixed amphetamine salts daily. Participants will be asked to take the medication once per day in the morning or early afternoon and will be maintained on this schedule through week 14 of the trial. Computer-assisted behavior therapy based on the Community Reinforcement Approach (CRA) to treating cocaine dependence. CRA is skills based treatment program that incorporates coping skills development and contingency management. Participants will attend the clinic 3x per week and receive counseling 2x per week.
Computer-assisted behavior therapy: TES is a computer-assisted therapy program delivered via effective informational and multimedia technologies, includes 32 core interactive, multimedia modules, beginning with basic cognitive behavioral relapse prevention skills (e.g. drug refusal skills) and moving on to improving psychosocial functioning, (e.g. employment status, social relations) and HIV risk reduction.
Mixed amphetamine salts: 80 mg/day of Adderall-XR and computer -assisted CBT
|
Computer-assisted CBT Plus Placebo
n=41 participants at risk
Patients who are randomized to the Computer-assisted CBT plus placebo arm will have their medication dose titrated in a fix-flexible dose schedule matching the active medication arm. Participants will be asked to take the medication once per day in the morning or early afternoon and will be maintained on this schedule through week 14 of the trial. Computer-assisted behavior therapy based on the Community Reinforcement Approach (CRA) to treating cocaine dependence. CRA is skills based treatment program that incorporates coping skills development and contingency management. Participants will attend the clinic 3x per week and receive counseling 2x per week.
Computer-assisted behavior therapy: TES is a computer-assisted therapy program delivered via effective informational and multimedia technologies, includes 32 core interactive, multimedia modules, beginning with basic cognitive behavioral relapse prevention skills (e.g. drug refusal skills) and moving on to improving psychosocial functioning, (e.g. employment status, social relations) and HIV risk reduction.
Placebo: Will receive computer -assisted CBT and placebo (instead of active Adderall-XR)
|
Non-randomized CBT Plus CM
n=59 participants at risk
Fifty nine individuals who were not randomized and only exposed to CBT and CM. 21 participants were designated as treatment responders during the first month of the psychosocial intervention and were not randomized. An additional 38 individuals were lost to follow-up or not eligible to be randomized prior to completing the first month of the intervention.
|
|---|---|---|---|
|
General disorders
inpatient rehabilitation stay
|
0.00%
0/45 • During 15 weeks of trial, or length of individual's participation
Adverse events are reported for those individuals randomized to either of the two arms MAS-ER or placebo as well as those non-randomized individuals who received CBT plus CM
|
2.4%
1/41 • Number of events 1 • During 15 weeks of trial, or length of individual's participation
Adverse events are reported for those individuals randomized to either of the two arms MAS-ER or placebo as well as those non-randomized individuals who received CBT plus CM
|
1.7%
1/59 • Number of events 1 • During 15 weeks of trial, or length of individual's participation
Adverse events are reported for those individuals randomized to either of the two arms MAS-ER or placebo as well as those non-randomized individuals who received CBT plus CM
|
|
General disorders
dehydration
|
2.2%
1/45 • Number of events 1 • During 15 weeks of trial, or length of individual's participation
Adverse events are reported for those individuals randomized to either of the two arms MAS-ER or placebo as well as those non-randomized individuals who received CBT plus CM
|
0.00%
0/41 • During 15 weeks of trial, or length of individual's participation
Adverse events are reported for those individuals randomized to either of the two arms MAS-ER or placebo as well as those non-randomized individuals who received CBT plus CM
|
0.00%
0/59 • During 15 weeks of trial, or length of individual's participation
Adverse events are reported for those individuals randomized to either of the two arms MAS-ER or placebo as well as those non-randomized individuals who received CBT plus CM
|
|
General disorders
hernia
|
0.00%
0/45 • During 15 weeks of trial, or length of individual's participation
Adverse events are reported for those individuals randomized to either of the two arms MAS-ER or placebo as well as those non-randomized individuals who received CBT plus CM
|
0.00%
0/41 • During 15 weeks of trial, or length of individual's participation
Adverse events are reported for those individuals randomized to either of the two arms MAS-ER or placebo as well as those non-randomized individuals who received CBT plus CM
|
1.7%
1/59 • Number of events 1 • During 15 weeks of trial, or length of individual's participation
Adverse events are reported for those individuals randomized to either of the two arms MAS-ER or placebo as well as those non-randomized individuals who received CBT plus CM
|
|
Cardiac disorders
atrial fibrillation
|
0.00%
0/45 • During 15 weeks of trial, or length of individual's participation
Adverse events are reported for those individuals randomized to either of the two arms MAS-ER or placebo as well as those non-randomized individuals who received CBT plus CM
|
0.00%
0/41 • During 15 weeks of trial, or length of individual's participation
Adverse events are reported for those individuals randomized to either of the two arms MAS-ER or placebo as well as those non-randomized individuals who received CBT plus CM
|
1.7%
1/59 • Number of events 1 • During 15 weeks of trial, or length of individual's participation
Adverse events are reported for those individuals randomized to either of the two arms MAS-ER or placebo as well as those non-randomized individuals who received CBT plus CM
|
|
Gastrointestinal disorders
GI issue
|
0.00%
0/45 • During 15 weeks of trial, or length of individual's participation
Adverse events are reported for those individuals randomized to either of the two arms MAS-ER or placebo as well as those non-randomized individuals who received CBT plus CM
|
0.00%
0/41 • During 15 weeks of trial, or length of individual's participation
Adverse events are reported for those individuals randomized to either of the two arms MAS-ER or placebo as well as those non-randomized individuals who received CBT plus CM
|
1.7%
1/59 • Number of events 1 • During 15 weeks of trial, or length of individual's participation
Adverse events are reported for those individuals randomized to either of the two arms MAS-ER or placebo as well as those non-randomized individuals who received CBT plus CM
|
Other adverse events
| Measure |
Computer-assisted CBT Plus Mixed-Amphetamine Salts- Extended Release (MAS-ER)
n=45 participants at risk
Patients who are randomized to the computer-assisted behavior therapy plus mixed amphetamine salts (extended release) arm will have their dose titrated to 80 mg or the maximum tolerated extended release mixed amphetamine salts daily. Participants will be asked to take the medication once per day in the morning or early afternoon and will be maintained on this schedule through week 14 of the trial. Computer-assisted behavior therapy based on the Community Reinforcement Approach (CRA) to treating cocaine dependence. CRA is skills based treatment program that incorporates coping skills development and contingency management. Participants will attend the clinic 3x per week and receive counseling 2x per week.
Computer-assisted behavior therapy: TES is a computer-assisted therapy program delivered via effective informational and multimedia technologies, includes 32 core interactive, multimedia modules, beginning with basic cognitive behavioral relapse prevention skills (e.g. drug refusal skills) and moving on to improving psychosocial functioning, (e.g. employment status, social relations) and HIV risk reduction.
Mixed amphetamine salts: 80 mg/day of Adderall-XR and computer -assisted CBT
|
Computer-assisted CBT Plus Placebo
n=41 participants at risk
Patients who are randomized to the Computer-assisted CBT plus placebo arm will have their medication dose titrated in a fix-flexible dose schedule matching the active medication arm. Participants will be asked to take the medication once per day in the morning or early afternoon and will be maintained on this schedule through week 14 of the trial. Computer-assisted behavior therapy based on the Community Reinforcement Approach (CRA) to treating cocaine dependence. CRA is skills based treatment program that incorporates coping skills development and contingency management. Participants will attend the clinic 3x per week and receive counseling 2x per week.
Computer-assisted behavior therapy: TES is a computer-assisted therapy program delivered via effective informational and multimedia technologies, includes 32 core interactive, multimedia modules, beginning with basic cognitive behavioral relapse prevention skills (e.g. drug refusal skills) and moving on to improving psychosocial functioning, (e.g. employment status, social relations) and HIV risk reduction.
Placebo: Will receive computer -assisted CBT and placebo (instead of active Adderall-XR)
|
Non-randomized CBT Plus CM
n=59 participants at risk
Fifty nine individuals who were not randomized and only exposed to CBT and CM. 21 participants were designated as treatment responders during the first month of the psychosocial intervention and were not randomized. An additional 38 individuals were lost to follow-up or not eligible to be randomized prior to completing the first month of the intervention.
|
|---|---|---|---|
|
General disorders
insomnia
|
31.1%
14/45 • Number of events 14 • During 15 weeks of trial, or length of individual's participation
Adverse events are reported for those individuals randomized to either of the two arms MAS-ER or placebo as well as those non-randomized individuals who received CBT plus CM
|
4.9%
2/41 • Number of events 2 • During 15 weeks of trial, or length of individual's participation
Adverse events are reported for those individuals randomized to either of the two arms MAS-ER or placebo as well as those non-randomized individuals who received CBT plus CM
|
0.00%
0/59 • During 15 weeks of trial, or length of individual's participation
Adverse events are reported for those individuals randomized to either of the two arms MAS-ER or placebo as well as those non-randomized individuals who received CBT plus CM
|
|
Psychiatric disorders
anxiety
|
22.2%
10/45 • Number of events 10 • During 15 weeks of trial, or length of individual's participation
Adverse events are reported for those individuals randomized to either of the two arms MAS-ER or placebo as well as those non-randomized individuals who received CBT plus CM
|
7.3%
3/41 • Number of events 3 • During 15 weeks of trial, or length of individual's participation
Adverse events are reported for those individuals randomized to either of the two arms MAS-ER or placebo as well as those non-randomized individuals who received CBT plus CM
|
1.7%
1/59 • Number of events 1 • During 15 weeks of trial, or length of individual's participation
Adverse events are reported for those individuals randomized to either of the two arms MAS-ER or placebo as well as those non-randomized individuals who received CBT plus CM
|
|
Gastrointestinal disorders
nausea
|
20.0%
9/45 • Number of events 9 • During 15 weeks of trial, or length of individual's participation
Adverse events are reported for those individuals randomized to either of the two arms MAS-ER or placebo as well as those non-randomized individuals who received CBT plus CM
|
4.9%
2/41 • Number of events 2 • During 15 weeks of trial, or length of individual's participation
Adverse events are reported for those individuals randomized to either of the two arms MAS-ER or placebo as well as those non-randomized individuals who received CBT plus CM
|
0.00%
0/59 • During 15 weeks of trial, or length of individual's participation
Adverse events are reported for those individuals randomized to either of the two arms MAS-ER or placebo as well as those non-randomized individuals who received CBT plus CM
|
|
General disorders
irritability
|
11.1%
5/45 • Number of events 5 • During 15 weeks of trial, or length of individual's participation
Adverse events are reported for those individuals randomized to either of the two arms MAS-ER or placebo as well as those non-randomized individuals who received CBT plus CM
|
7.3%
3/41 • Number of events 3 • During 15 weeks of trial, or length of individual's participation
Adverse events are reported for those individuals randomized to either of the two arms MAS-ER or placebo as well as those non-randomized individuals who received CBT plus CM
|
0.00%
0/59 • During 15 weeks of trial, or length of individual's participation
Adverse events are reported for those individuals randomized to either of the two arms MAS-ER or placebo as well as those non-randomized individuals who received CBT plus CM
|
|
Cardiac disorders
hypertension
|
13.3%
6/45 • Number of events 6 • During 15 weeks of trial, or length of individual's participation
Adverse events are reported for those individuals randomized to either of the two arms MAS-ER or placebo as well as those non-randomized individuals who received CBT plus CM
|
4.9%
2/41 • Number of events 2 • During 15 weeks of trial, or length of individual's participation
Adverse events are reported for those individuals randomized to either of the two arms MAS-ER or placebo as well as those non-randomized individuals who received CBT plus CM
|
0.00%
0/59 • During 15 weeks of trial, or length of individual's participation
Adverse events are reported for those individuals randomized to either of the two arms MAS-ER or placebo as well as those non-randomized individuals who received CBT plus CM
|
|
General disorders
headache
|
6.7%
3/45 • Number of events 3 • During 15 weeks of trial, or length of individual's participation
Adverse events are reported for those individuals randomized to either of the two arms MAS-ER or placebo as well as those non-randomized individuals who received CBT plus CM
|
7.3%
3/41 • Number of events 3 • During 15 weeks of trial, or length of individual's participation
Adverse events are reported for those individuals randomized to either of the two arms MAS-ER or placebo as well as those non-randomized individuals who received CBT plus CM
|
1.7%
1/59 • Number of events 1 • During 15 weeks of trial, or length of individual's participation
Adverse events are reported for those individuals randomized to either of the two arms MAS-ER or placebo as well as those non-randomized individuals who received CBT plus CM
|
|
General disorders
appetite loss
|
8.9%
4/45 • Number of events 4 • During 15 weeks of trial, or length of individual's participation
Adverse events are reported for those individuals randomized to either of the two arms MAS-ER or placebo as well as those non-randomized individuals who received CBT plus CM
|
2.4%
1/41 • Number of events 1 • During 15 weeks of trial, or length of individual's participation
Adverse events are reported for those individuals randomized to either of the two arms MAS-ER or placebo as well as those non-randomized individuals who received CBT plus CM
|
0.00%
0/59 • During 15 weeks of trial, or length of individual's participation
Adverse events are reported for those individuals randomized to either of the two arms MAS-ER or placebo as well as those non-randomized individuals who received CBT plus CM
|
|
General disorders
dry mouth
|
8.9%
4/45 • Number of events 4 • During 15 weeks of trial, or length of individual's participation
Adverse events are reported for those individuals randomized to either of the two arms MAS-ER or placebo as well as those non-randomized individuals who received CBT plus CM
|
2.4%
1/41 • Number of events 1 • During 15 weeks of trial, or length of individual's participation
Adverse events are reported for those individuals randomized to either of the two arms MAS-ER or placebo as well as those non-randomized individuals who received CBT plus CM
|
0.00%
0/59 • During 15 weeks of trial, or length of individual's participation
Adverse events are reported for those individuals randomized to either of the two arms MAS-ER or placebo as well as those non-randomized individuals who received CBT plus CM
|
|
Gastrointestinal disorders
constipation
|
6.7%
3/45 • Number of events 3 • During 15 weeks of trial, or length of individual's participation
Adverse events are reported for those individuals randomized to either of the two arms MAS-ER or placebo as well as those non-randomized individuals who received CBT plus CM
|
4.9%
2/41 • Number of events 2 • During 15 weeks of trial, or length of individual's participation
Adverse events are reported for those individuals randomized to either of the two arms MAS-ER or placebo as well as those non-randomized individuals who received CBT plus CM
|
0.00%
0/59 • During 15 weeks of trial, or length of individual's participation
Adverse events are reported for those individuals randomized to either of the two arms MAS-ER or placebo as well as those non-randomized individuals who received CBT plus CM
|
Additional Information
Kenneth Carpenter, PhD
New York State Psychiatric Institute
Phone: 646-774-8181
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place