Trial Outcomes & Findings for Observational Study of Misuse of High Dose Buprenorphine (Subutex® or Generic) in Opiate-Addicted Patients in France (Study P05186AM1)(COMPLETED) (NCT NCT00723697)

Last Updated: 2023-03-20

Results Overview

Number of patients who indicate misuse behaviours on self-questionnaire response at first (D1), 6 month (M6), and 12 month (M12) visits.

Recruitment status

COMPLETED

Target enrollment

1307 participants

Primary outcome timeframe

first visit, 6 months, and 12 months

Results posted on

2023-03-20

Participant Flow

Participant milestones

Participant milestones
Measure	Patients Patients addicted to opiates and requiring replacement treatment. Patients in this non-interventional study were prescribed treatment as per usual clinical practice.
Overall Study STARTED	1307
Overall Study COMPLETED	1289
Overall Study NOT COMPLETED	18

Reasons for withdrawal

Reasons for withdrawal
Measure	Patients Patients addicted to opiates and requiring replacement treatment. Patients in this non-interventional study were prescribed treatment as per usual clinical practice.
Overall Study Physician questionnaires not received	2
Overall Study Missing Informed Consent Form	10
Overall Study Other exclusion criteria applied	6

Baseline Characteristics

Observational Study of Misuse of High Dose Buprenorphine (Subutex® or Generic) in Opiate-Addicted Patients in France (Study P05186AM1)(COMPLETED)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Patients n=879 Participants Patients addicted to opiates and requiring replacement treatment. Patients in this non-interventional study were prescribed treatment as per usual clinical practice.
Age, Continuous	34.70 years n=99 Participants
Sex: Female, Male Female	192 Participants n=99 Participants
Sex: Female, Male Male	687 Participants n=99 Participants

PRIMARY outcome

Timeframe: first visit, 6 months, and 12 months

Population: Number of patients with self-questionnaire responses.

Number of patients who indicate misuse behaviours on self-questionnaire response at first (D1), 6 month (M6), and 12 month (M12) visits.

Outcome measures

Outcome measures
Measure	Patients at First Visit n=880 Participants Patients addicted to opiates and requiring replacement treatment. Patients in this non-interventional study were prescribed treatment as per usual clinical practice.	Patients at 6 Month Visit Patients addicted to opiates and requiring replacement treatment. Patients in this non-interventional study were prescribed treatment as per usual clinical practice.	Patients at 12 Month Visit Patients addicted to opiates and requiring replacement treatment. Patients in this non-interventional study were prescribed treatment as per usual clinical practice.
Number of Patients Reporting Misuse (Injection, Sniffing, Dose Fractionation, Modification of Prescribed Doses, and Combination With Psychotropic Agents) Proper usage at all visits (no misuse)	131 participants Interval 30.61 to 39.57	—	—
Number of Patients Reporting Misuse (Injection, Sniffing, Dose Fractionation, Modification of Prescribed Doses, and Combination With Psychotropic Agents) Misuse at M12 only	20 participants	—	—
Number of Patients Reporting Misuse (Injection, Sniffing, Dose Fractionation, Modification of Prescribed Doses, and Combination With Psychotropic Agents) Misuse at M6 only	15 participants	—	—
Number of Patients Reporting Misuse (Injection, Sniffing, Dose Fractionation, Modification of Prescribed Doses, and Combination With Psychotropic Agents) Misuse at D1 only	38 participants	—	—
Number of Patients Reporting Misuse (Injection, Sniffing, Dose Fractionation, Modification of Prescribed Doses, and Combination With Psychotropic Agents) Misuse at M6 and M12 only	19 participants	—	—
Number of Patients Reporting Misuse (Injection, Sniffing, Dose Fractionation, Modification of Prescribed Doses, and Combination With Psychotropic Agents) Misuse at all visits	151 participants	—	—
Number of Patients Reporting Misuse (Injection, Sniffing, Dose Fractionation, Modification of Prescribed Doses, and Combination With Psychotropic Agents) Missing Data	448 participants	—	—
Number of Patients Reporting Misuse (Injection, Sniffing, Dose Fractionation, Modification of Prescribed Doses, and Combination With Psychotropic Agents) Misuse at D1 and M12 only	24 participants	—	—
Number of Patients Reporting Misuse (Injection, Sniffing, Dose Fractionation, Modification of Prescribed Doses, and Combination With Psychotropic Agents) Misuse at D1 and M6 only	34 participants	—	—

PRIMARY outcome

Timeframe: first visit, 6 months, and 12 months

Population: All eligible patients

Number of patients with misuse behaviours on physician-questionnaire response at first (D1), 6 month (M6), and 12 month (M12) visits.

Outcome measures

Outcome measures
Measure	Patients at First Visit n=1289 Participants Patients addicted to opiates and requiring replacement treatment. Patients in this non-interventional study were prescribed treatment as per usual clinical practice.	Patients at 6 Month Visit Patients addicted to opiates and requiring replacement treatment. Patients in this non-interventional study were prescribed treatment as per usual clinical practice.	Patients at 12 Month Visit Patients addicted to opiates and requiring replacement treatment. Patients in this non-interventional study were prescribed treatment as per usual clinical practice.
Number of Patients With Misuse (Injection, Sniffing, Dose Fractionation, Modification of Prescribed Doses, and Combination With Psychotropic Agents) as Reported by Physician. Misuse at all visits	407 participants	—	—
Number of Patients With Misuse (Injection, Sniffing, Dose Fractionation, Modification of Prescribed Doses, and Combination With Psychotropic Agents) as Reported by Physician. Missing Data	295 participants	—	—
Number of Patients With Misuse (Injection, Sniffing, Dose Fractionation, Modification of Prescribed Doses, and Combination With Psychotropic Agents) as Reported by Physician. Proper usage at all visits (no misuse)	206 participants	—	—
Number of Patients With Misuse (Injection, Sniffing, Dose Fractionation, Modification of Prescribed Doses, and Combination With Psychotropic Agents) as Reported by Physician. Misuse at M12 only	37 participants	—	—
Number of Patients With Misuse (Injection, Sniffing, Dose Fractionation, Modification of Prescribed Doses, and Combination With Psychotropic Agents) as Reported by Physician. Misuse at M6 only	37 participants	—	—
Number of Patients With Misuse (Injection, Sniffing, Dose Fractionation, Modification of Prescribed Doses, and Combination With Psychotropic Agents) as Reported by Physician. Misuse at D1 only	134 participants	—	—
Number of Patients With Misuse (Injection, Sniffing, Dose Fractionation, Modification of Prescribed Doses, and Combination With Psychotropic Agents) as Reported by Physician. Misuse at M6 and M12 only	52 participants	—	—
Number of Patients With Misuse (Injection, Sniffing, Dose Fractionation, Modification of Prescribed Doses, and Combination With Psychotropic Agents) as Reported by Physician. Misuse at D1 and M12 only	49 participants	—	—
Number of Patients With Misuse (Injection, Sniffing, Dose Fractionation, Modification of Prescribed Doses, and Combination With Psychotropic Agents) as Reported by Physician. Misuse at D1 and M6 only	72 participants	—	—

SECONDARY outcome

Timeframe: first visit, 6 months, and 12 months

Population: Number of patients analyzed for the consequence, at each visit.

Number of patients with clinical consequences (development or progression of: abscess, nutritional deficiency, dental problems, psychiatric problems including depression, sleep problems, schizophrenia, anxiety, phobias, hallucinations, delirium, withdrawal symptoms, inhibition, suicide attempts and other problems) at first, 6 month, and/or 12 month visit.

Outcome measures

Outcome measures
Measure	Patients at First Visit n=1289 Participants Patients addicted to opiates and requiring replacement treatment. Patients in this non-interventional study were prescribed treatment as per usual clinical practice.	Patients at 6 Month Visit n=1136 Participants Patients addicted to opiates and requiring replacement treatment. Patients in this non-interventional study were prescribed treatment as per usual clinical practice.	Patients at 12 Month Visit n=1024 Participants Patients addicted to opiates and requiring replacement treatment. Patients in this non-interventional study were prescribed treatment as per usual clinical practice.
Number of Patients Reporting Clinical Consequences of Engaging in Misuse abscesses (n=1288/1134/1022)	41 participants	29 participants	31 participants
Number of Patients Reporting Clinical Consequences of Engaging in Misuse nutritional deficiency (n=1288/1134/1022)	99 participants	65 participants	63 participants
Number of Patients Reporting Clinical Consequences of Engaging in Misuse dental problems (n=1287/1133/1022)	459 participants	293 participants	244 participants
Number of Patients Reporting Clinical Consequences of Engaging in Misuse psychiatric problems (n=1288/1133/1022)	504 participants	364 participants	329 participants
Number of Patients Reporting Clinical Consequences of Engaging in Misuse depression (n=502/359/325)	230 participants	174 participants	157 participants
Number of Patients Reporting Clinical Consequences of Engaging in Misuse schizophrenia (n=499/356/326)	18 participants	15 participants	15 participants
Number of Patients Reporting Clinical Consequences of Engaging in Misuse sleep disturbances (n=500/360/327)	336 participants	228 participants	200 participants
Number of Patients Reporting Clinical Consequences of Engaging in Misuse anxiety (n=500/360/326)	335 participants	222 participants	200 participants
Number of Patients Reporting Clinical Consequences of Engaging in Misuse delirium/hallucinations (n=499/358/327)	26 participants	21 participants	17 participants
Number of Patients Reporting Clinical Consequences of Engaging in Misuse suicide attempts (n=499/357/326)	42 participants	14 participants	12 participants
Number of Patients Reporting Clinical Consequences of Engaging in Misuse other psychiatric problems (n=487/355/326)	28 participants	14 participants	18 participants
Number of Patients Reporting Clinical Consequences of Engaging in Misuse autistic withdrawal, inhibition (n=500/357/326)	89 participants	50 participants	43 participants

Adverse Events

Patients

Serious events: 34 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Patients n=1305 participants at risk
Cardiac disorders CARDIAC DISORDER	0.08% 1/1305 • Number of events 1 Two patients who did not have a first visit were excluded from the adverse event database.
Endocrine disorders HYPERTHYROIDISM	0.08% 1/1305 • Number of events 1 Two patients who did not have a first visit were excluded from the adverse event database.
Gastrointestinal disorders CONSTIPATION	0.08% 1/1305 • Number of events 1 Two patients who did not have a first visit were excluded from the adverse event database.
Gastrointestinal disorders GASTROINTESTINAL STENOSIS	0.08% 1/1305 • Number of events 1 Two patients who did not have a first visit were excluded from the adverse event database.
General disorders GENERAL PHYSICAL HEALTH DETERIORATION	0.08% 1/1305 • Number of events 1 Two patients who did not have a first visit were excluded from the adverse event database.
General disorders INJECTION SITE NECROSIS	0.38% 5/1305 • Number of events 8 Two patients who did not have a first visit were excluded from the adverse event database.
General disorders OEDEMA	0.46% 6/1305 • Number of events 7 Two patients who did not have a first visit were excluded from the adverse event database.
Hepatobiliary disorders LIVER DISORDER	0.08% 1/1305 • Number of events 1 Two patients who did not have a first visit were excluded from the adverse event database.
Infections and infestations INJECTION SITE ABSCESS	0.69% 9/1305 • Number of events 10 Two patients who did not have a first visit were excluded from the adverse event database.
Infections and infestations PSOAS ABSCESS	0.08% 1/1305 • Number of events 1 Two patients who did not have a first visit were excluded from the adverse event database.
Infections and infestations TUBERCULOSIS	0.08% 1/1305 • Number of events 1 Two patients who did not have a first visit were excluded from the adverse event database.
Injury, poisoning and procedural complications ROAD TRAFFIC ACCIDENT	0.08% 1/1305 • Number of events 1 Two patients who did not have a first visit were excluded from the adverse event database.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) SALIVARY GLAND CANCER	0.08% 1/1305 • Number of events 1 Two patients who did not have a first visit were excluded from the adverse event database.
Nervous system disorders CEREBROVASCULAR ACCIDENT	0.08% 1/1305 • Number of events 1 Two patients who did not have a first visit were excluded from the adverse event database.
Nervous system disorders STATUS EPILEPTICUS	0.08% 1/1305 • Number of events 3 Two patients who did not have a first visit were excluded from the adverse event database.
Pregnancy, puerperium and perinatal conditions PREMATURE LABOUR	0.08% 1/1305 • Number of events 1 Two patients who did not have a first visit were excluded from the adverse event database.
Psychiatric disorders DRUG DEPENDENCE	0.08% 1/1305 • Number of events 1 Two patients who did not have a first visit were excluded from the adverse event database.
Psychiatric disorders INSOMNIA	0.08% 1/1305 • Number of events 1 Two patients who did not have a first visit were excluded from the adverse event database.
Psychiatric disorders MENTAL DISORDER	0.54% 7/1305 • Number of events 7 Two patients who did not have a first visit were excluded from the adverse event database.
Psychiatric disorders WITHDRAWAL SYNDROME	0.23% 3/1305 • Number of events 3 Two patients who did not have a first visit were excluded from the adverse event database.
Respiratory, thoracic and mediastinal disorders RESPIRATORY DEPRESSION	0.08% 1/1305 • Number of events 1 Two patients who did not have a first visit were excluded from the adverse event database.
Social circumstances ALCOHOL USE	0.08% 1/1305 • Number of events 1 Two patients who did not have a first visit were excluded from the adverse event database.
Surgical and medical procedures DRUG DETOXIFICATION	0.15% 2/1305 • Number of events 2 Two patients who did not have a first visit were excluded from the adverse event database.
Vascular disorders AORTIC ANEURYSM RUPTURE	0.08% 1/1305 • Number of events 1 Two patients who did not have a first visit were excluded from the adverse event database.
Vascular disorders PHLEBITIS	0.15% 2/1305 • Number of events 2 Two patients who did not have a first visit were excluded from the adverse event database.

Other adverse events

Adverse event data not reported

Additional Information

Vice President of Late Stage Development

Merck Sharp & Dohme Corp

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee No publication (abstract, poster, communication...) can be made without the agreement of SCHERING-PLOUGH.
Publication restrictions are in place

Restriction type: OTHER