Ibogaine treatment outcomes for opioid dependence from a twelve-month follow-up observational study

Figures & data

Table 1. Published reports of Ibogaine administrations to opioid-dependent patients.

Study	N	Dependence*	Period Assessed Post-Tx	Dosage Ibogaine HCl	Outcomes
					(Withdrawal [WD], Craving [CR], Use)
Sheppard 1994 (33)	7	o	≤ 14 weeks	11.7–25 mg/kg	No WD
					Use @ 2 days (n = 4)
					No use @ 14 weeks (n = 3)
					CR Not reported
Luciano 1998 (34)	3	2 (c) 1 (h)	24 hours	20–25 mg/kg	No WD
					Use, CR Not reported
Alper 1999 (11)	33‡	h, m	≤72 hours	6–29 mg/kg	No WD/CR/Use (n = 25)
					No WD but use post-Tx (n = 4)
					WD/CR and Use post-Tx (n = 1) 1 fatality
Mash 2000 (35)	27	h, c	≤ 14 days Post-Tx	500, 600, 800mg (e.g., 8–12 mg/kg)	Aggregate reduction in BDI (p = .0005);
			1 month		ASI (p = .0001)
			Post-Tx		WD/CR Not reported
Mash 2001 (27)	32	h, m	12–72 hr	800 mg	WD reduced ≤72 hours (p <.05)
			Post-Tx		CR Not reported
Bastiaans 2004 (36)	21	o (n = 18)	Retro-spective ≈ 22 months	Unspecified dose (n = 18) “extract” (typically 50–70% ibogaine; n = 3) 48% treated twice	No use @ 7 days (n = 19)
					No use primary drug ≈ 1.5 yrs (n = 9)
					No use at 3.5yrs (n = 5) (anecdotal) CR Not reported

*h = heroin, m = methadone, o = opioids, c = cocaine, Tx = treatment

‡Includes the 7 participants from [27].

Table 2. Schedule of subject interviews (14) and data collection, with outcome measures to 12-months post-tx.

Interview	Months Post-tx	ASI	BDI	SOWS	Drug Screen	Talk
1	Pre-tx	X	X	X
2	Post-tx		X	X
3	1	X	X
4	2					X
5	3	X	X
6	4					X
7	5					X
8	6	X	X		X
9	7					X
10	8					X
11	9	X	X		X
12	10					X
13	11					X
14	12	X	X		X

Figure 1. CONSORT diagram showing participant flow through observational study.

Table 3. SOWS scores comparing pre-administration baseline with post-administration 12–24 hours, and baseline with post-administration 42–84 hours.

	Mean	N	Std	p Value
Baseline	25.21	14	12.57	0.015*
12–24 hours	14.21	14	14.08
Baseline	24.00	6	16.84	0.070
42–84 hours	8.50	6	3.72

*p < 0.05 compared with baseline (reduction in mean indicates improvement).

Table 4. ASI summary statistics at baseline and 12-month follow-up.

	Baseline		12-month Follow-up
Average score	N	mean (std)	N	mean (std)
Medical	8	0.00 (0.00)	8	0.34 (0.40)*
Employment	8	0.37 (0.40)	8	0.22 (0.33)
Alcohol	8	0.16 (0.26)	8	0.08 (0.08)
Drug	8	0.32 (0.07)	8	0.06 (0.08)**
Legal	8	0.00 (0.00)	8	0.01 (0.04)
Family/Social	8	0.11 (0.15)	8	0.09 (0.13)
Psychiatric	8	0.11 (0.15)	8	0.05 (0.11)

*p < 0.05 compared with baseline

**p < 0.01 compared with baseline.

Table 5. BDI-II scores at baseline; immediately post-treatment; and at 1-, 3-, 6-, 9-, and 12-month follow-up.

	BDI
Treatment (Tx) time	N	mean total score (std)	p Value (time x cf baseline)
Pre-Tx (Baseline)	14	22.1 (10.8)
Immediate post-tx	14	16.4 (12.3)	0.102
1- month post-tx	13	9.3 (7.6)	0.013
3-months post-tx	13	6.2 (5.3)	0.002
6-months post-tx	12	7.8 (9.9)	0.008
9-months post-tx	12	8.8 (10.6)	0.008
12-months post-tx	11	4.4.25 (5.3)	0.004

Table 6. Percentages of participants in observed cases reporting urine screen data for opioid use at 3, 6, and 12 months post-ibogaine treatment.

Months Post-Tx (Total N)	Missing N	Positive N (%)	Negative N (%)
3 months (14)	6	1 (12.5%)	7 (87.5%)
6 months (14)	7	1 (14.3%)	6 (85.7%)
12 months* (11)	3	2 (25.0%)	6 (75.0%)

*By 12 months one subject had withdrawn and two had been lost to follow-up.

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