Trial Outcomes & Findings for Effects of ABT-089 on Smoking Abstinence Symptoms and Reward (NCT NCT01756053)
NCT ID: NCT01756053
Last Updated: 2014-10-29
Results Overview
We will assess whether ABT-089 ameliorates the cognitive deficits due to smoking abstinence. To assess, all subjects will complete a computerized N-Back task during the Testing Day Session (Days 6 \& 37) in each study medication period. Each Testing Day session occurs after 24 hours of abstinence from smoking. During one study medication period, subjects will take active ABT-089; during the other period, subjects will take a matched placebo. Each of the task conditions (0-, 1-, 2-, and 3-back) will be administered in a pseudorandomized counterbalanced order. Each difficulty level will consist of one block of 50 trials, preceded by a practice block of 20 trials. The primary dependent variables for this task are total number of correct responses (out of 60) and reaction time (milliseconds). All computerized neurocognitive tasks are completed in a quiet, standardized environment in our clinic. NOTE: Each PPT completes 1 Baseline (no tx.) and 2 Testing Days (ABT/Placebo)
TERMINATED
PHASE2
17 participants
Baseline (Day 0) and Test Day (Days 6 & 37)
2014-10-29
Participant Flow
Fifty three subjects were consented and screened for eligibility at an Intake Visit between April 2013 and December 2013 at the Center for Interdisciplinary Research on Nicotine Addiction (Philadelphia, PA).
Seventeen of the 53 subjects were randomized and received study medication. Of those NOT randomized, 30 were deemed ineligible and 6 withdrew from the study.
Participant milestones
| Measure |
ABT-089, Then Placebo
Those randomized to active ABT-089 during study medication period 1 will take four 10mg capsules daily (40mg daily) during a 10-day medication period. After a washout period of \~21 days, these subjects will then take four capsules of matching placebo daily for a second 10-day medication period.
ABT-089: Selective neuronal nicotinic receptor agonist.
|
Placebo, Then ABT-089
Those randomized to placebo (matching ABT-089 10 mg capsules) during study medication period 1 will take four capsules daily during a 10-day medication period. After a washout period of \~21 days, these subjects will then take four 10 mg capsules (40 mg) daily of ABT-089 for a second 10-day study medication period.
Placebo: Matching placebo capsules supplied by study drug supplier.
|
|---|---|---|
|
Period 1 (10 Days)
STARTED
|
8
|
9
|
|
Period 1 (10 Days)
COMPLETED
|
7
|
8
|
|
Period 1 (10 Days)
NOT COMPLETED
|
1
|
1
|
|
Washout Period (~21 Days)
STARTED
|
7
|
8
|
|
Washout Period (~21 Days)
COMPLETED
|
7
|
8
|
|
Washout Period (~21 Days)
NOT COMPLETED
|
0
|
0
|
|
Period 2 (10 Days)
STARTED
|
7
|
8
|
|
Period 2 (10 Days)
COMPLETED
|
7
|
6
|
|
Period 2 (10 Days)
NOT COMPLETED
|
0
|
2
|
Reasons for withdrawal
| Measure |
ABT-089, Then Placebo
Those randomized to active ABT-089 during study medication period 1 will take four 10mg capsules daily (40mg daily) during a 10-day medication period. After a washout period of \~21 days, these subjects will then take four capsules of matching placebo daily for a second 10-day medication period.
ABT-089: Selective neuronal nicotinic receptor agonist.
|
Placebo, Then ABT-089
Those randomized to placebo (matching ABT-089 10 mg capsules) during study medication period 1 will take four capsules daily during a 10-day medication period. After a washout period of \~21 days, these subjects will then take four 10 mg capsules (40 mg) daily of ABT-089 for a second 10-day study medication period.
Placebo: Matching placebo capsules supplied by study drug supplier.
|
|---|---|---|
|
Period 1 (10 Days)
Protocol Violation
|
1
|
1
|
|
Period 2 (10 Days)
Protocol Violation
|
0
|
2
|
Baseline Characteristics
Effects of ABT-089 on Smoking Abstinence Symptoms and Reward
Baseline characteristics by cohort
| Measure |
All Study Subjects
n=17 Participants
Subjects who were randomized and received their Period 1 study medication (ABT-089 or matching placebo).
|
|---|---|
|
Age, Continuous
|
41.76471 Years
STANDARD_DEVIATION 11.20563 • n=5 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
12 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
13 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
4 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
17 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline (Day 0) and Test Day (Days 6 & 37)Population: Only participants completing both study periods (n=13) were included in the analyses.
We will assess whether ABT-089 ameliorates the cognitive deficits due to smoking abstinence. To assess, all subjects will complete a computerized N-Back task during the Testing Day Session (Days 6 \& 37) in each study medication period. Each Testing Day session occurs after 24 hours of abstinence from smoking. During one study medication period, subjects will take active ABT-089; during the other period, subjects will take a matched placebo. Each of the task conditions (0-, 1-, 2-, and 3-back) will be administered in a pseudorandomized counterbalanced order. Each difficulty level will consist of one block of 50 trials, preceded by a practice block of 20 trials. The primary dependent variables for this task are total number of correct responses (out of 60) and reaction time (milliseconds). All computerized neurocognitive tasks are completed in a quiet, standardized environment in our clinic. NOTE: Each PPT completes 1 Baseline (no tx.) and 2 Testing Days (ABT/Placebo)
Outcome measures
| Measure |
ABT-089
n=13 Participants
Subjects who were assigned to active ABT-089 (four 10 mg capsules daily) in either Period 1 or Period 2 of the study. Each study period is 10 days.
|
Placebo
n=13 Participants
Subjects who were assigned to matched placebo (four capsules daily) in either Period 1 or Period 2 of the study. Each study period is 10 days.
|
|---|---|---|
|
Change in Abstinence-induced Cognitive Deficits (N-Back Accuracy)
Baseline (Day 0)
|
44.2 Number of correct responses (out of 60)
Standard Deviation 7.2
|
44.2 Number of correct responses (out of 60)
Standard Deviation 7.2
|
|
Change in Abstinence-induced Cognitive Deficits (N-Back Accuracy)
Test Days (Days 6 & 37)
|
47.5 Number of correct responses (out of 60)
Standard Deviation 8.4
|
47.5 Number of correct responses (out of 60)
Standard Deviation 8.4
|
PRIMARY outcome
Timeframe: Baseline (Day 0) and Test Day (Days 6 & 37)Population: Only participants completing both study periods (n=13) were included in the analyses.
We will assess whether ABT-089 ameliorates the cognitive deficits due to smoking abstinence. To assess, all subjects will complete a computerized N-Back task during the Testing Day Session (Days 6 \& 37) in each study medication period. Each Testing Day session occurs after 24 hours of abstinence from smoking. During one study medication period, subjects will take active ABT-089; during the other period, subjects will take a matched placebo. Each of the task conditions (0-, 1-, 2-, and 3-back) will be administered in a pseudorandomized counterbalanced order. Each difficulty level will consist of one block of 50 trials, preceded by a practice block of 20 trials. The primary dependent variables for this task are total number of correct responses (out of 60) and reaction time (milliseconds). All computerized neurocognitive tasks are completed in a quiet, standardized environment in our clinic. NOTE: Each PPT completes 1 Baseline (no tx.) and 2 Testing Days (ABT/Placebo)
Outcome measures
| Measure |
ABT-089
n=13 Participants
Subjects who were assigned to active ABT-089 (four 10 mg capsules daily) in either Period 1 or Period 2 of the study. Each study period is 10 days.
|
Placebo
n=13 Participants
Subjects who were assigned to matched placebo (four capsules daily) in either Period 1 or Period 2 of the study. Each study period is 10 days.
|
|---|---|---|
|
Change in Abstinence-induced Cognitive Deficits (N-Back Correct Response Time)
Baseline (Day 0)
|
612.4 Milliseconds
Standard Deviation 125.5
|
612.4 Milliseconds
Standard Deviation 125.5
|
|
Change in Abstinence-induced Cognitive Deficits (N-Back Correct Response Time)
Test Days (Days 6 & 37)
|
646.5 Milliseconds
Standard Deviation 143.3
|
638.9 Milliseconds
Standard Deviation 129.5
|
SECONDARY outcome
Timeframe: Days 6 and 37Population: Only participants completing both study periods (n=13) were included in the analyses.
PANAS: The Positive and Negative Affect Schedule (PANAS), a 20-item Likert-format self-report measure, was used to assess Positive Affect (PA; 10 items, e.g., enthusiastic, strong) and Negative Affect (NA; 10 items, e.g., distressed, upset), two dominant and generally orthogonal dimensions of affect. Scores for the 10 items on each subscale were summed to create summary scores (range: 10-50); higher scores indicate greater intensity of mood (i.e., more positive or more negative affect). Higher ratings of positive affect and lower ratings of negative affect are considered better outcomes.
Outcome measures
| Measure |
ABT-089
n=13 Participants
Subjects who were assigned to active ABT-089 (four 10 mg capsules daily) in either Period 1 or Period 2 of the study. Each study period is 10 days.
|
Placebo
n=13 Participants
Subjects who were assigned to matched placebo (four capsules daily) in either Period 1 or Period 2 of the study. Each study period is 10 days.
|
|---|---|---|
|
Effects of ABT-089 on Mood
PANAS: Positive Affect
|
25.4 Scores on a scale
Standard Deviation 9.2
|
26.2 Scores on a scale
Standard Deviation 9.6
|
|
Effects of ABT-089 on Mood
PANAS: Negative Affect
|
13.2 Scores on a scale
Standard Deviation 3.6
|
13.5 Scores on a scale
Standard Deviation 4.6
|
SECONDARY outcome
Timeframe: Days 6 and 37Population: Only participants completing both study periods (n=13) were included in the analyses.
MNWS: The Minnesota Nicotine Withdrawal Scale - Revised version captures the current state of nicotine withdrawal. The scale assesses 15 items of nicotine withdrawal (including 7 DSM-IV items) such as: dysphoria or depressed mood, insomnia, irritability/frustration/anger, anxiety, difficulty concentrating, restlessness, and increased appetite/weight gain. Subjects will rate the intensity of their symptoms on the following scale: 0 = none, 1 = slight, 2 = mild, 3 = moderate, 4 = severe. A "withdrawal discomfort score" was calculated as the sum of the first 9 items (possible range: 0-36) and is a well-validated measure of nicotine withdrawal; a higher score indicates more severe withdrawal.
Outcome measures
| Measure |
ABT-089
n=13 Participants
Subjects who were assigned to active ABT-089 (four 10 mg capsules daily) in either Period 1 or Period 2 of the study. Each study period is 10 days.
|
Placebo
n=13 Participants
Subjects who were assigned to matched placebo (four capsules daily) in either Period 1 or Period 2 of the study. Each study period is 10 days.
|
|---|---|---|
|
Effects of ABT-089 on Withdrawal Symptoms
|
6.8 Scores on a scale
Standard Deviation 6.1
|
6.6 Scores on a scale
Standard Deviation 6.7
|
SECONDARY outcome
Timeframe: Days 6 and 37Population: Only participants completing both study periods (n=13) were included in the analyses.
QSU-B: The 10-item brief QSU (QSU-B) questionnaire was used to assess smoking urges. Each item is rated on a 7-point scale (1 = strongly disagree, 7 = strongly agree). A total score is calculated as the sum of the individual items (range: 10-70). Higher scores indicate more severe urges to smoke.
Outcome measures
| Measure |
ABT-089
n=13 Participants
Subjects who were assigned to active ABT-089 (four 10 mg capsules daily) in either Period 1 or Period 2 of the study. Each study period is 10 days.
|
Placebo
n=13 Participants
Subjects who were assigned to matched placebo (four capsules daily) in either Period 1 or Period 2 of the study. Each study period is 10 days.
|
|---|---|---|
|
Effects of ABT-089 on Smoking Urges/Craving
|
37.4 Scores on a scale
Standard Deviation 17.2
|
38.3 Scores on a scale
Standard Deviation 15.8
|
SECONDARY outcome
Timeframe: Days 6 and 37Population: Only participants completing both study periods (n=13) were included in the analyses.
ADHD symptoms: The 27-item BAARS-IV scale was used to assess current attention-deficit and hyperactive symptoms. Participant rated the intensity of their symptoms using the following scale: 1= never or rarely, 2 = sometimes, 3 = often, or 4 = very often. A total score was calculated as the sum of the individual items (range: 27-108). Higher scores indicate more frequent ADHD symptoms.
Outcome measures
| Measure |
ABT-089
n=13 Participants
Subjects who were assigned to active ABT-089 (four 10 mg capsules daily) in either Period 1 or Period 2 of the study. Each study period is 10 days.
|
Placebo
n=13 Participants
Subjects who were assigned to matched placebo (four capsules daily) in either Period 1 or Period 2 of the study. Each study period is 10 days.
|
|---|---|---|
|
Effects of ABT-089 on Attention-deficit and Hyperactive Symptoms
|
33.2 Scores on a scale
Standard Deviation 6.8
|
35.4 Scores on a scale
Standard Deviation 9.6
|
SECONDARY outcome
Timeframe: Days 6 and 37Population: Only participants completing both study periods (n=13) were included in the analyses.
Cigarette evaluation scale: The Cigarette Evaluation Scale (CES), developed to assess subjective effects of smoking, is an 11-item Likert-format measure. Questions include items for nausea and dizziness, craving relief, and enjoyment of airway sensations. Items are rated on a scale from 1 ("Not at all") to 7 ("Extremely); a summary score is calculated as the mean of all responses (range: 1-7). Higher scores indicate stronger subjective effects of smoking.
Outcome measures
| Measure |
ABT-089
n=13 Participants
Subjects who were assigned to active ABT-089 (four 10 mg capsules daily) in either Period 1 or Period 2 of the study. Each study period is 10 days.
|
Placebo
n=13 Participants
Subjects who were assigned to matched placebo (four capsules daily) in either Period 1 or Period 2 of the study. Each study period is 10 days.
|
|---|---|---|
|
Effects of ABT-089 on Cigarette Ratings
|
2.8 Scores on a scale
Standard Deviation 0.78
|
2.9 Scores on a scale
Standard Deviation 0.76
|
SECONDARY outcome
Timeframe: Days 7, 8, 9, 10, 38, 39, 40, & 41Population: Only participants completing both study periods (n=13) were included in the analyses.
Daily smoking rate will be assessed at each in-person visit using the Timeline Follow-Back assessment. Abstinence will be confirmed by exhaled carbon monoxide levels during a \~4-day monitored abstinence phase within each period.
Outcome measures
| Measure |
ABT-089
n=13 Participants
Subjects who were assigned to active ABT-089 (four 10 mg capsules daily) in either Period 1 or Period 2 of the study. Each study period is 10 days.
|
Placebo
n=13 Participants
Subjects who were assigned to matched placebo (four capsules daily) in either Period 1 or Period 2 of the study. Each study period is 10 days.
|
|---|---|---|
|
Effects of ABT-089 on Days of Biochemically-confirmed Abstinence
|
1.2 Days of abstinence
Standard Deviation 1.7
|
1.2 Days of abstinence
Standard Deviation 1.8
|
Adverse Events
ABT-089
Placebo
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
ABT-089
n=16 participants at risk
Subjects were assigned to take four 10 mg capsules daily (40 mg daily) during a 10-day medication period.
ABT-089: Selective neuronal nicotinic receptor agonist.
|
Placebo
n=16 participants at risk
Subjects were assigned to take four placebo capsules (matching ABT-089 10 mg) daily during a 10-day medication period.
Placebo: Matched placebo capsules supplied by study drug supplier.
|
|---|---|---|
|
Gastrointestinal disorders
Diarrhea
|
12.5%
2/16 • Number of events 2 • 10 days for each study medication period (ABT-089/Placebo in counter-balanced order)
The safety population described within this section includes all subjects who received at least one dose of ABT-089 (n=16) or Placebo (n=16). Systematic Assessment: Subjects completed a side effect checklist at every in-person study visit over the course of the treatment period. Subjects could also spontaneously report AEs at any time.
|
6.2%
1/16 • Number of events 1 • 10 days for each study medication period (ABT-089/Placebo in counter-balanced order)
The safety population described within this section includes all subjects who received at least one dose of ABT-089 (n=16) or Placebo (n=16). Systematic Assessment: Subjects completed a side effect checklist at every in-person study visit over the course of the treatment period. Subjects could also spontaneously report AEs at any time.
|
|
Gastrointestinal disorders
Nausea
|
12.5%
2/16 • Number of events 4 • 10 days for each study medication period (ABT-089/Placebo in counter-balanced order)
The safety population described within this section includes all subjects who received at least one dose of ABT-089 (n=16) or Placebo (n=16). Systematic Assessment: Subjects completed a side effect checklist at every in-person study visit over the course of the treatment period. Subjects could also spontaneously report AEs at any time.
|
18.8%
3/16 • Number of events 4 • 10 days for each study medication period (ABT-089/Placebo in counter-balanced order)
The safety population described within this section includes all subjects who received at least one dose of ABT-089 (n=16) or Placebo (n=16). Systematic Assessment: Subjects completed a side effect checklist at every in-person study visit over the course of the treatment period. Subjects could also spontaneously report AEs at any time.
|
|
General disorders
Fatigue
|
12.5%
2/16 • Number of events 3 • 10 days for each study medication period (ABT-089/Placebo in counter-balanced order)
The safety population described within this section includes all subjects who received at least one dose of ABT-089 (n=16) or Placebo (n=16). Systematic Assessment: Subjects completed a side effect checklist at every in-person study visit over the course of the treatment period. Subjects could also spontaneously report AEs at any time.
|
18.8%
3/16 • Number of events 4 • 10 days for each study medication period (ABT-089/Placebo in counter-balanced order)
The safety population described within this section includes all subjects who received at least one dose of ABT-089 (n=16) or Placebo (n=16). Systematic Assessment: Subjects completed a side effect checklist at every in-person study visit over the course of the treatment period. Subjects could also spontaneously report AEs at any time.
|
|
General disorders
Irritability
|
50.0%
8/16 • Number of events 22 • 10 days for each study medication period (ABT-089/Placebo in counter-balanced order)
The safety population described within this section includes all subjects who received at least one dose of ABT-089 (n=16) or Placebo (n=16). Systematic Assessment: Subjects completed a side effect checklist at every in-person study visit over the course of the treatment period. Subjects could also spontaneously report AEs at any time.
|
68.8%
11/16 • Number of events 30 • 10 days for each study medication period (ABT-089/Placebo in counter-balanced order)
The safety population described within this section includes all subjects who received at least one dose of ABT-089 (n=16) or Placebo (n=16). Systematic Assessment: Subjects completed a side effect checklist at every in-person study visit over the course of the treatment period. Subjects could also spontaneously report AEs at any time.
|
|
Musculoskeletal and connective tissue disorders
Muscle Weakness
|
12.5%
2/16 • Number of events 3 • 10 days for each study medication period (ABT-089/Placebo in counter-balanced order)
The safety population described within this section includes all subjects who received at least one dose of ABT-089 (n=16) or Placebo (n=16). Systematic Assessment: Subjects completed a side effect checklist at every in-person study visit over the course of the treatment period. Subjects could also spontaneously report AEs at any time.
|
6.2%
1/16 • Number of events 2 • 10 days for each study medication period (ABT-089/Placebo in counter-balanced order)
The safety population described within this section includes all subjects who received at least one dose of ABT-089 (n=16) or Placebo (n=16). Systematic Assessment: Subjects completed a side effect checklist at every in-person study visit over the course of the treatment period. Subjects could also spontaneously report AEs at any time.
|
|
Nervous system disorders
Headache
|
12.5%
2/16 • Number of events 7 • 10 days for each study medication period (ABT-089/Placebo in counter-balanced order)
The safety population described within this section includes all subjects who received at least one dose of ABT-089 (n=16) or Placebo (n=16). Systematic Assessment: Subjects completed a side effect checklist at every in-person study visit over the course of the treatment period. Subjects could also spontaneously report AEs at any time.
|
37.5%
6/16 • Number of events 12 • 10 days for each study medication period (ABT-089/Placebo in counter-balanced order)
The safety population described within this section includes all subjects who received at least one dose of ABT-089 (n=16) or Placebo (n=16). Systematic Assessment: Subjects completed a side effect checklist at every in-person study visit over the course of the treatment period. Subjects could also spontaneously report AEs at any time.
|
|
Psychiatric disorders
Anxiety
|
37.5%
6/16 • Number of events 18 • 10 days for each study medication period (ABT-089/Placebo in counter-balanced order)
The safety population described within this section includes all subjects who received at least one dose of ABT-089 (n=16) or Placebo (n=16). Systematic Assessment: Subjects completed a side effect checklist at every in-person study visit over the course of the treatment period. Subjects could also spontaneously report AEs at any time.
|
50.0%
8/16 • Number of events 20 • 10 days for each study medication period (ABT-089/Placebo in counter-balanced order)
The safety population described within this section includes all subjects who received at least one dose of ABT-089 (n=16) or Placebo (n=16). Systematic Assessment: Subjects completed a side effect checklist at every in-person study visit over the course of the treatment period. Subjects could also spontaneously report AEs at any time.
|
|
Psychiatric disorders
Hostility
|
18.8%
3/16 • Number of events 7 • 10 days for each study medication period (ABT-089/Placebo in counter-balanced order)
The safety population described within this section includes all subjects who received at least one dose of ABT-089 (n=16) or Placebo (n=16). Systematic Assessment: Subjects completed a side effect checklist at every in-person study visit over the course of the treatment period. Subjects could also spontaneously report AEs at any time.
|
43.8%
7/16 • Number of events 17 • 10 days for each study medication period (ABT-089/Placebo in counter-balanced order)
The safety population described within this section includes all subjects who received at least one dose of ABT-089 (n=16) or Placebo (n=16). Systematic Assessment: Subjects completed a side effect checklist at every in-person study visit over the course of the treatment period. Subjects could also spontaneously report AEs at any time.
|
|
Psychiatric disorders
Tension
|
31.2%
5/16 • Number of events 16 • 10 days for each study medication period (ABT-089/Placebo in counter-balanced order)
The safety population described within this section includes all subjects who received at least one dose of ABT-089 (n=16) or Placebo (n=16). Systematic Assessment: Subjects completed a side effect checklist at every in-person study visit over the course of the treatment period. Subjects could also spontaneously report AEs at any time.
|
43.8%
7/16 • Number of events 21 • 10 days for each study medication period (ABT-089/Placebo in counter-balanced order)
The safety population described within this section includes all subjects who received at least one dose of ABT-089 (n=16) or Placebo (n=16). Systematic Assessment: Subjects completed a side effect checklist at every in-person study visit over the course of the treatment period. Subjects could also spontaneously report AEs at any time.
|
|
Psychiatric disorders
Depressed Mood
|
6.2%
1/16 • Number of events 1 • 10 days for each study medication period (ABT-089/Placebo in counter-balanced order)
The safety population described within this section includes all subjects who received at least one dose of ABT-089 (n=16) or Placebo (n=16). Systematic Assessment: Subjects completed a side effect checklist at every in-person study visit over the course of the treatment period. Subjects could also spontaneously report AEs at any time.
|
6.2%
1/16 • Number of events 1 • 10 days for each study medication period (ABT-089/Placebo in counter-balanced order)
The safety population described within this section includes all subjects who received at least one dose of ABT-089 (n=16) or Placebo (n=16). Systematic Assessment: Subjects completed a side effect checklist at every in-person study visit over the course of the treatment period. Subjects could also spontaneously report AEs at any time.
|
|
Psychiatric disorders
Agitation
|
56.2%
9/16 • Number of events 20 • 10 days for each study medication period (ABT-089/Placebo in counter-balanced order)
The safety population described within this section includes all subjects who received at least one dose of ABT-089 (n=16) or Placebo (n=16). Systematic Assessment: Subjects completed a side effect checklist at every in-person study visit over the course of the treatment period. Subjects could also spontaneously report AEs at any time.
|
56.2%
9/16 • Number of events 21 • 10 days for each study medication period (ABT-089/Placebo in counter-balanced order)
The safety population described within this section includes all subjects who received at least one dose of ABT-089 (n=16) or Placebo (n=16). Systematic Assessment: Subjects completed a side effect checklist at every in-person study visit over the course of the treatment period. Subjects could also spontaneously report AEs at any time.
|
|
Psychiatric disorders
Vivid Dreams
|
25.0%
4/16 • Number of events 4 • 10 days for each study medication period (ABT-089/Placebo in counter-balanced order)
The safety population described within this section includes all subjects who received at least one dose of ABT-089 (n=16) or Placebo (n=16). Systematic Assessment: Subjects completed a side effect checklist at every in-person study visit over the course of the treatment period. Subjects could also spontaneously report AEs at any time.
|
25.0%
4/16 • Number of events 6 • 10 days for each study medication period (ABT-089/Placebo in counter-balanced order)
The safety population described within this section includes all subjects who received at least one dose of ABT-089 (n=16) or Placebo (n=16). Systematic Assessment: Subjects completed a side effect checklist at every in-person study visit over the course of the treatment period. Subjects could also spontaneously report AEs at any time.
|
|
Psychiatric disorders
Insomnia
|
12.5%
2/16 • Number of events 6 • 10 days for each study medication period (ABT-089/Placebo in counter-balanced order)
The safety population described within this section includes all subjects who received at least one dose of ABT-089 (n=16) or Placebo (n=16). Systematic Assessment: Subjects completed a side effect checklist at every in-person study visit over the course of the treatment period. Subjects could also spontaneously report AEs at any time.
|
25.0%
4/16 • Number of events 6 • 10 days for each study medication period (ABT-089/Placebo in counter-balanced order)
The safety population described within this section includes all subjects who received at least one dose of ABT-089 (n=16) or Placebo (n=16). Systematic Assessment: Subjects completed a side effect checklist at every in-person study visit over the course of the treatment period. Subjects could also spontaneously report AEs at any time.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
6.2%
1/16 • Number of events 3 • 10 days for each study medication period (ABT-089/Placebo in counter-balanced order)
The safety population described within this section includes all subjects who received at least one dose of ABT-089 (n=16) or Placebo (n=16). Systematic Assessment: Subjects completed a side effect checklist at every in-person study visit over the course of the treatment period. Subjects could also spontaneously report AEs at any time.
|
0.00%
0/16 • 10 days for each study medication period (ABT-089/Placebo in counter-balanced order)
The safety population described within this section includes all subjects who received at least one dose of ABT-089 (n=16) or Placebo (n=16). Systematic Assessment: Subjects completed a side effect checklist at every in-person study visit over the course of the treatment period. Subjects could also spontaneously report AEs at any time.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/16 • 10 days for each study medication period (ABT-089/Placebo in counter-balanced order)
The safety population described within this section includes all subjects who received at least one dose of ABT-089 (n=16) or Placebo (n=16). Systematic Assessment: Subjects completed a side effect checklist at every in-person study visit over the course of the treatment period. Subjects could also spontaneously report AEs at any time.
|
6.2%
1/16 • Number of events 1 • 10 days for each study medication period (ABT-089/Placebo in counter-balanced order)
The safety population described within this section includes all subjects who received at least one dose of ABT-089 (n=16) or Placebo (n=16). Systematic Assessment: Subjects completed a side effect checklist at every in-person study visit over the course of the treatment period. Subjects could also spontaneously report AEs at any time.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
6.2%
1/16 • Number of events 3 • 10 days for each study medication period (ABT-089/Placebo in counter-balanced order)
The safety population described within this section includes all subjects who received at least one dose of ABT-089 (n=16) or Placebo (n=16). Systematic Assessment: Subjects completed a side effect checklist at every in-person study visit over the course of the treatment period. Subjects could also spontaneously report AEs at any time.
|
0.00%
0/16 • 10 days for each study medication period (ABT-089/Placebo in counter-balanced order)
The safety population described within this section includes all subjects who received at least one dose of ABT-089 (n=16) or Placebo (n=16). Systematic Assessment: Subjects completed a side effect checklist at every in-person study visit over the course of the treatment period. Subjects could also spontaneously report AEs at any time.
|
|
General disorders
Pyrexia
|
6.2%
1/16 • Number of events 1 • 10 days for each study medication period (ABT-089/Placebo in counter-balanced order)
The safety population described within this section includes all subjects who received at least one dose of ABT-089 (n=16) or Placebo (n=16). Systematic Assessment: Subjects completed a side effect checklist at every in-person study visit over the course of the treatment period. Subjects could also spontaneously report AEs at any time.
|
0.00%
0/16 • 10 days for each study medication period (ABT-089/Placebo in counter-balanced order)
The safety population described within this section includes all subjects who received at least one dose of ABT-089 (n=16) or Placebo (n=16). Systematic Assessment: Subjects completed a side effect checklist at every in-person study visit over the course of the treatment period. Subjects could also spontaneously report AEs at any time.
|
|
Respiratory, thoracic and mediastinal disorders
Throat Irritation
|
0.00%
0/16 • 10 days for each study medication period (ABT-089/Placebo in counter-balanced order)
The safety population described within this section includes all subjects who received at least one dose of ABT-089 (n=16) or Placebo (n=16). Systematic Assessment: Subjects completed a side effect checklist at every in-person study visit over the course of the treatment period. Subjects could also spontaneously report AEs at any time.
|
18.8%
3/16 • Number of events 5 • 10 days for each study medication period (ABT-089/Placebo in counter-balanced order)
The safety population described within this section includes all subjects who received at least one dose of ABT-089 (n=16) or Placebo (n=16). Systematic Assessment: Subjects completed a side effect checklist at every in-person study visit over the course of the treatment period. Subjects could also spontaneously report AEs at any time.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/16 • 10 days for each study medication period (ABT-089/Placebo in counter-balanced order)
The safety population described within this section includes all subjects who received at least one dose of ABT-089 (n=16) or Placebo (n=16). Systematic Assessment: Subjects completed a side effect checklist at every in-person study visit over the course of the treatment period. Subjects could also spontaneously report AEs at any time.
|
6.2%
1/16 • Number of events 1 • 10 days for each study medication period (ABT-089/Placebo in counter-balanced order)
The safety population described within this section includes all subjects who received at least one dose of ABT-089 (n=16) or Placebo (n=16). Systematic Assessment: Subjects completed a side effect checklist at every in-person study visit over the course of the treatment period. Subjects could also spontaneously report AEs at any time.
|
Additional Information
Benjamin Albelda (Project Manager)
Center for Interdisciplinary Research on Nicotine Addiction
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place