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Trial Outcomes & Findings for Effectiveness of Lofexidine to Prevent Stress-Related Opiate Relapse During Naltrexone Treatment - 1 (NCT NCT00142909)

NCT ID: NCT00142909

Last Updated: 2015-07-30

Results Overview

The Subjective Opiate Withdrawal Scale (SOWS) consists of 16 symptoms rated in intensity by patients on a 5-point scale of intensity as follows: 0=not at all, 1=a little, 2=moderately, 3=quite a bit, 4=extremely. The total score is a sum of item ratings, and ranges from 0 to 64. The greater the score, the greater the intensity of Opiate Withdrawal. Source: Reprinted from Handelsman et al. 1987, p. 296, by courtesy of Marcel Dekker, Inc.Other Sources: Gossop 1990; Bradley et al. 1987. ACCESSED: http://www.ncbi.nlm.nih.gov/books/NBK64244/

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

86 participants

Primary outcome timeframe

1 Week

Results posted on

2015-07-30

Participant Flow

Participant milestones

Participant milestones
Measure
Lofexidine
Lofexidine: Study medication Participants will receive daily lofexidine and the dosing will be initiated at 0.4 mg bid and increased to 0.8mg in week 1 and 1.0 and 1.2 mg bid in week 2, and maintained at 1.2mg bid for weeks 3 to 12. They are then tapered down to 0 over the course of four days in week 12. While the target dose will be 2.4 mg daily, if any subject shows reduced tolerability at this or a lower dose, the dose will be adjusted to the maximum tolerated dose for that subject.
Placebo
Participants will receive daily placebo and follow the same schedule as the active intervention for 12 weeks.
Randomization
STARTED
42
44
Randomization
COMPLETED
35
34
Randomization
NOT COMPLETED
7
10
Medications Begin
STARTED
35
34
Medications Begin
COMPLETED
26
31
Medications Begin
NOT COMPLETED
9
3

Reasons for withdrawal

Reasons for withdrawal
Measure
Lofexidine
Lofexidine: Study medication Participants will receive daily lofexidine and the dosing will be initiated at 0.4 mg bid and increased to 0.8mg in week 1 and 1.0 and 1.2 mg bid in week 2, and maintained at 1.2mg bid for weeks 3 to 12. They are then tapered down to 0 over the course of four days in week 12. While the target dose will be 2.4 mg daily, if any subject shows reduced tolerability at this or a lower dose, the dose will be adjusted to the maximum tolerated dose for that subject.
Placebo
Participants will receive daily placebo and follow the same schedule as the active intervention for 12 weeks.
Randomization
Various Reasons
7
10
Medications Begin
Protocol Violation
2
0
Medications Begin
Withdrawal by Subject
2
0

Baseline Characteristics

Effectiveness of Lofexidine to Prevent Stress-Related Opiate Relapse During Naltrexone Treatment - 1

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Lofexidine
n=35 Participants
Placebo
n=34 Participants
Total
n=69 Participants
Total of all reporting groups
Age, Continuous
28.63 years
STANDARD_DEVIATION 9.99 • n=5 Participants
25.56 years
STANDARD_DEVIATION 7.66 • n=7 Participants
26.24 years
STANDARD_DEVIATION 7.96 • n=5 Participants
Sex: Female, Male
Female
8 Participants
n=5 Participants
7 Participants
n=7 Participants
15 Participants
n=5 Participants
Sex: Female, Male
Male
27 Participants
n=5 Participants
27 Participants
n=7 Participants
54 Participants
n=5 Participants
Race/Ethnicity, Customized
African American
2 participants
n=5 Participants
1 participants
n=7 Participants
3 participants
n=5 Participants
Race/Ethnicity, Customized
Caucasian
32 participants
n=5 Participants
31 participants
n=7 Participants
63 participants
n=5 Participants
Race/Ethnicity, Customized
Hispanic
1 participants
n=5 Participants
1 participants
n=7 Participants
2 participants
n=5 Participants
Race/Ethnicity, Customized
Other
0 participants
n=5 Participants
1 participants
n=7 Participants
1 participants
n=5 Participants

PRIMARY outcome

Timeframe: 1 Week

The Subjective Opiate Withdrawal Scale (SOWS) consists of 16 symptoms rated in intensity by patients on a 5-point scale of intensity as follows: 0=not at all, 1=a little, 2=moderately, 3=quite a bit, 4=extremely. The total score is a sum of item ratings, and ranges from 0 to 64. The greater the score, the greater the intensity of Opiate Withdrawal. Source: Reprinted from Handelsman et al. 1987, p. 296, by courtesy of Marcel Dekker, Inc.Other Sources: Gossop 1990; Bradley et al. 1987. ACCESSED: http://www.ncbi.nlm.nih.gov/books/NBK64244/

Outcome measures

Outcome measures
Measure
Lofexidine
n=26 Participants
Lofexidine: Study medication
Placebo
n=31 Participants
Placebo pill
SOWS: the Subjective Opiate Withdrawal Scale
11.5 units on a scale
Standard Deviation 9.7
12.5 units on a scale
Standard Deviation 6.7

PRIMARY outcome

Timeframe: 12 weeks

The Subjective Opiate Withdrawal Scale (SOWS) consists of 16 symptoms rated in intensity by patients on a 5-point scale of intensity as follows: 0=not at all, 1=a little, 2=moderately, 3=quite a bit, 4=extremely. The total score is a sum of item ratings, and ranges from 0 to 64. The greater the score, the greater the intensity of Opiate Withdrawal. Source: Reprinted from Handelsman et al. 1987, p. 296, by courtesy of Marcel Dekker, Inc.Other Sources: Gossop 1990; Bradley et al. 1987. ACCESSED: http://www.ncbi.nlm.nih.gov/books/NBK64244/

Outcome measures

Outcome measures
Measure
Lofexidine
n=26 Participants
Lofexidine: Study medication
Placebo
n=31 Participants
Placebo pill
SOWS: the Subjective Opiate Withdrawal Scale
2.9 units on a scale
Standard Deviation 5.8
5.0 units on a scale
Standard Deviation 13.3

SECONDARY outcome

Timeframe: 1 Week

Outcome measures

Outcome measures
Measure
Lofexidine
n=26 Participants
Lofexidine: Study medication
Placebo
n=31 Participants
Placebo pill
Systolic Blood Pressure
115.3 mm Hg
Standard Deviation 10.1
126.0 mm Hg
Standard Deviation 12.0

SECONDARY outcome

Timeframe: 12 weeks

Outcome measures

Outcome measures
Measure
Lofexidine
n=26 Participants
Lofexidine: Study medication
Placebo
n=31 Participants
Placebo pill
Systolic Blood Pressure
122.3 mm Hg
Standard Deviation 10.1
126.7 mm Hg
Standard Deviation 8.9

SECONDARY outcome

Timeframe: 1 Week

Outcome measures

Outcome measures
Measure
Lofexidine
n=26 Participants
Lofexidine: Study medication
Placebo
n=31 Participants
Placebo pill
Diastolic Blood Pressure
68.2 mm Hg
Standard Deviation 7.6
73.4 mm Hg
Standard Deviation 7.6

SECONDARY outcome

Timeframe: 12 weeks

Outcome measures

Outcome measures
Measure
Lofexidine
n=26 Participants
Lofexidine: Study medication
Placebo
n=31 Participants
Placebo pill
Diastolic Blood Pressure
74.4 mm Hg
Standard Deviation 12.5
76.1 mm Hg
Standard Deviation 7.8

Adverse Events

Lofexidine

Serious events: 0 serious events
Other events: 16 other events
Deaths: 0 deaths

Placebo

Serious events: 0 serious events
Other events: 14 other events
Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure
Lofexidine
n=26 participants at risk
Lofexidine: Study medication
Placebo
n=31 participants at risk
Placebo pill
Nervous system disorders
Headache
34.6%
9/26 • Number of events 9 • 12 weeks
32.3%
10/31 • Number of events 10 • 12 weeks
Nervous system disorders
Dizzy/lightheaded
34.6%
9/26 • Number of events 9 • 12 weeks
9.7%
3/31 • Number of events 3 • 12 weeks
Nervous system disorders
Tired/fatigued
46.2%
12/26 • Number of events 12 • 12 weeks
12.9%
4/31 • Number of events 4 • 12 weeks
Gastrointestinal disorders
Abdominal Pain
19.2%
5/26 • Number of events 5 • 12 weeks
9.7%
3/31 • Number of events 3 • 12 weeks
Skin and subcutaneous tissue disorders
Acne
11.5%
3/26 • Number of events 3 • 12 weeks
0.00%
0/31 • 12 weeks
Skin and subcutaneous tissue disorders
Rash
3.8%
1/26 • Number of events 1 • 12 weeks
6.5%
2/31 • Number of events 2 • 12 weeks
Gastrointestinal disorders
Diarrhea
11.5%
3/26 • Number of events 3 • 12 weeks
12.9%
4/31 • Number of events 4 • 12 weeks
Ear and labyrinth disorders
Earache/infection
3.8%
1/26 • Number of events 1 • 12 weeks
6.5%
2/31 • Number of events 2 • 12 weeks
Respiratory, thoracic and mediastinal disorders
Sore Throat
11.5%
3/26 • Number of events 3 • 12 weeks
22.6%
7/31 • Number of events 7 • 12 weeks
Gastrointestinal disorders
Nausea/Vomiting
23.1%
6/26 • Number of events 6 • 12 weeks
16.1%
5/31 • Number of events 5 • 12 weeks
Respiratory, thoracic and mediastinal disorders
Cold Symptoms
26.9%
7/26 • Number of events 7 • 12 weeks
32.3%
10/31 • Number of events 10 • 12 weeks
Cardiac disorders
Increased Heart Rate
3.8%
1/26 • Number of events 1 • 12 weeks
6.5%
2/31 • Number of events 2 • 12 weeks
Vascular disorders
Low Blood Pressure
11.5%
3/26 • Number of events 3 • 12 weeks
0.00%
0/31 • 12 weeks
Psychiatric disorders
Anxiety
3.8%
1/26 • Number of events 1 • 12 weeks
0.00%
0/31 • 12 weeks
General disorders
Aches
15.4%
4/26 • Number of events 4 • 12 weeks
25.8%
8/31 • Number of events 8 • 12 weeks
General disorders
Weight Gain/Loss
3.8%
1/26 • Number of events 1 • 12 weeks
6.5%
2/31 • Number of events 2 • 12 weeks

Additional Information

Rajita Sinha, Ph.D

Yale University School of Medicine

Phone: 203-737-5805

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place