Heroin addiction
Conditions
Interventions
TTX 1:5ug TTX injection
TTX 2:10ugTTX injection
placebo:Placebo
Sponsors
Sichuan University of West China Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 55 Years
Inclusion criteria
Inclusion criteria: (1) Diagnostic and Statistical Manual of Mental Disorders, 4th edition, criteria for heroin dependence; (2) men or non-pregnant/non-nursing women aged 18-55 years; (3) positive urine test for heroin; (4) the last heroin dose was administered within 8-36 h, and (5) normal electrocardiogram and heart rate of 55-100 beats per minute.
Exclusion criteria
Exclusion criteria: (1) obvious agitation, impulsive behavior, severe dehydration, and severe malnutrition or a total score on the Opiate Withdrawal Scale (OWS) > 140 (Shaham et al., 2000); (2) abnormal kidney, liver, or lung function; (3) blood pressure < 85/55 mmHg; (4) sever infectious diseases; (5) current or past history of severe neurological or psychiatric illness; (6) positive for human immunodeficiency virus; (7) polydrug abuse; (8) participation in other clinical trials within 1 month, and (9) history of allergy to TTX or placebo or allergic diathesis. All of the participants gave written informed consent. (1) poor response to test drugs (i.e., Clinical Global Impression [CGI] score after 3-5 days of treatment was 6 or 7); (2) serious adverse event; (3) administration of other drugs that might interfere with the effects of the test drug; (4) withdrawn consent of the subject; (5) termination due to ethical and medical reasons, and (6) dropping out for nonmedical reasons.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| the severity of withdrawal symptom; | — |
Secondary
| Measure | Time frame |
|---|---|
| anxiety and depression;overall condition;the positive rate of urinary test; | — |
Countries
China
Contacts
Public ContactJie Shi
Outcome results
None listed